Commission Directive 96/77/EC of 2 December 1996 laying down specific purity criteria on food additives other than colours and sweeteners (Text with EEA relevance)
Modified by
  • Commission Directive 98/86/ECof 11 November 1998amending Commission Directive 96/77/EC laying down specific purity criteria on food additives other than colours and sweeteners(Text with EEA relevance), 398L0086, December 9, 1998
  • Commission Directive 2000/63/ECof 5 October 2000amending Directive 96/77/EC laying down specific purity criteria on food additives other than colours and sweeteners(Text with EEA relevance), 300L0063, October 30, 2000
  • Commission Directive 2001/30/ECof 2 May 2001amending Directive 96/77/EC laying down specific purity criteria on food additives other than colours and sweeteners(Text with EEA relevance), 301L0030, May 31, 2001
  • Commission Directive 2002/82/ECof 15 October 2002amending Directive 96/77/EC laying down specific purity criteria on food additives other than colours and sweeteners(Text with EEA relevance), 302L0082, October 28, 2002
  • Commission Directive 2003/95/ECof 27 October 2003amending Directive 96/77/EC laying down specific purity criteria on food additives other than colours and sweeteners(Text with EEA relevance), 303L0095, October 31, 2003
Commission Directive 96/77/ECof 2 December 1996laying down specific purity criteria on food additives other than colours and sweeteners(Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorized for use in foodstuffs intended for human consumptionOJ No L 40, 11. 2. 1989, p. 27., as amended by European Parliament and Council Directive 94/34/ECOJ No L 237, 10. 9. 1994, p. 1., and in particular Article 3 (3) (a) thereof,After consulting the Scientific Committee for Food,Whereas it is necessary to establish purity criteria for all additives other than colours and sweeteners mentioned in European Parliament and Council Directive 95/2/EC of 20 February 1995 on food additives other than colours and sweetenersOJ No L 61, 18. 3. 1995, p. 1.;Whereas it is necessary to replace the purity criteria set out in Council Directive 65/66/EEC of 26 January 1965 laying down specific criteria of purity for preservatives authorized for use in foodstuffs intended for human consumptionOJ No 22, 9. 2. 1965, p. 373., as last amended by Directive 86/604/EECOJ No L 352, 13. 12. 1986, p. 45.;Whereas it is necessary to replace the purity criteria set out in Council Directive 78/664/EEC of 25 July 1978 laying down specific criteria of purity for antioxidants which may be used in foodstuffs intended for human consumptionOJ No L 223, 14. 8. 1978, p. 30., as amended by Directive 82/712/EECOJ No L 297, 23. 10. 1982, p. 31.;Whereas Directives 65/66/EEC and 78/664/EEC should be repealed accordingly;Whereas it is necessary to take into acount the specifications and analytical techniques for additives as set out in the Codex Alimentarius as drafted by the Joint FAO/WHO Expert Committee on Food Additives (Jecfa);Whereas food additives, if prepared by production methods or starting materials significantly different from those included in the evaluation of the Scientific Committee for Food, or if different from those mentioned in this Directive, should be submitted for evaluation by the Scientific Committee for Food for the purposes of a full evaluation with emphasis on the purity criteria;Whereas, the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Foodstuffs,HAS ADOPTED THIS DIRECTIVE:
Article 1The purity criteria referred to in Article 3 (3) (a) of Directive 89/107/EEC for food additives other than colours and sweeteners, as mentioned in Directive 95/2/EC, are set out in the Annex hereto.
Article 2The purity criteria referred to in Article 1 replace the purity criteria set out in Directives 65/66/EEC, 78/663/EEC and 78/664/EEC.
Article 31.Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 July 1997. They shall immediately inform the Commission thereof.When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.2.Products put on the market or labelled before 1 July 1997 which do not comply with this Directive may be marketed until stocks are exhausted.
Article 4This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities.
Article 5This Directive is addressed to the Member States.
nullANNEX
Cobalt chloride TSC: dissolve approximately 65 g of cobalt chloride CoCl2·6H2O in a sufficient quantity of a mixture of 25 ml hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place exactly 5 ml of this solution in a round-bottomed flask containing 250 ml of iodine solution, add 5 ml of 3 % hydrogen peroxide, then 15 ml of a 20 % solution of sodium hydroxide. Boil for 10 minutes, allow to cool, add 2 g of potassium iodide and 20 ml of 25 % sulphuric acid. After the precipitate is completely dissolved, titrate the liberated iodine with sodium thiosulphate (0,1 N) in the presence of starch TS. 1 ml of sodium thiosulphate (0,1 N) corresponds to 23,80 mg of CoCl2·6H2O. Adjust final volume of solution by the addition of a sufficient quantity of the hydrochloric acid/water mixture to give a solution containing 59,5 mg of CoCl2·6H2O per ml.Ferric chloride TSC: dissolve approximately 55 g of ferric chloride in a sufficient quantity of a mixture of 25 ml of hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place 10 ml of this solution in a round-bottomed flask containing 250 ml of iodine solution, add 15 ml of water and 3 g of potassium iodide; leave the mixture to stand for 15 minutes. Dilute with 100 ml of water then titrate the liberated iodine with sodium thiosulphate (0,1 N) in the presence of starch TS. 1 ml of sodium thiosulphate (0,1 N) corresponds to 27,03 mg of FeCl3·6H2O. Adjust final volume of solution by the addition of a sufficient quantity of the hydrochloric acid/water to give a solution containing 45,0 mg of FeCl3·6H2O per ml.Copper sulphate TSC: dissolve approximate by 65 g of copper sulphate CuSO4·5H2O in a sufficient quantity of a mixture of 25 ml of hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place 10 ml of this solution in a round-bottomed flask containing 250 ml of iodine solution, add 40 ml of water, 4 ml of acetic acid and 3 g of potassium iodide. Titrate the liberated iodine with sodium thiosulphate (0,1 N) in the presence of starch TS. 1 ml of sodium thiosulphate (0,1 N) corresponds to 24,97 mg of CuSO4·5H2O. Adjust final volume of solution by the addition of a sufficient quantity of the hydrochloric acid/water mixture to give a solution containing 62,4 mg of CuSO4·5H2O per ml.Starch TS: triturate 0,5 g starch (potato starch, maize starch of soluble starch) with 5 ml of water; to the resulting paste add a sufficient quantity of water to give a total volume of 100 ml, strirring all the time. Boil for a few minutes, allow to cool, filter. The starch must be freshly prepared.When labelled "for food use", nitrite may only be sold in a mixture with salt or a salt substitute.E 200 SORBIC ACIDDefinitionIdentificationPurityE 202 POTASSIUM SORBATEDefinitionIdentificationPurityE 203 CALCIUM SORBATEDefinitionIdentificationPurityE 210 BENZOIC ACIDDefinitionIdentificationPurityE 211 SODIUM BENZOATEDefinitionIdentificationPurityE 212 POTASSIUM BENZOATEDefinitionIdentificationPurityE 213 CALCIUM BENZOATEDefinitionIdentificationPurityE 214 ETHYL p-HYDROXYBENZOATEDefinitionIdentificationPurityE 215 SODIUM ETHYL p-HYDROXYBENZOATEDefinitionIdentificationPurityE 216 PROPYL p-HYDROXYBENZOATEDefinitionIdentificationPurityE 217 SODIUM PROPYL p-HYDROXYBENZOATEDefinitionIdentificationPurityE 218 METHYL p-HYDROXYBENZOATEDefinitionIdentificationPurityE 219 SODIUM METHYL p-HYDROXYBENZOATEDefinitionIdentificationPurityE 220 SULPHUR DIOXIDEDefinitionIdentificationPurityE 221 SODIUM SULPHITEDefinitionIdentificationPurityE 222 SODIUM BISULPHITEDefinitionIdentificationPurityE 223 SODIUM METABISULPHITEDefinitionIdentificationPurityE 224 POTASSIUM METABISULPHITEDefinitionIdentificationPurityE 226 CALCIUM SULPHITEDefinitionIdentificationPurityE 227 CALCIUM BISULPHITEDefinitionIdentificationPurityE 228 POTASSIUM BISULPHITEDefinitionIdentificationPurityE 230 BIPHENYLDefinitionIdentificationPurityE 231 ORTHOPHENYLPHENOLDefinitionIdentificationPurityE 232 SODIUM ORTHOPHENYLPHENOLDefinitionIdentificationPurityE 233 THIABENDAZOLEDefinitionIdentificationPurityE 234 NISINPurityE 235 NATAMYCINIdentificationPurityE 239 HEXAMETHYLENE TETRAMINEDefinitionIdentificationPurityE 242 DIMETHYL DICARBONATEDefinitionIdentificationPurityE 249 POTASSIUM NITRITEDefinitionIdentificationPurityE 250 SODIUM NITRITEDefinitionIdentificationPurityE 251 SODIUM NITRATE1.SOLID SODIUM NITRATEDefinitionIdentificationPurityE 251 SODIUM NITRATE2.LIQUID SODIUM NITRATEIdentificationPurityE 252 POTASSIUM NITRATEDefinitionIdentificationPurityE 260 ACETIC ACIDDefinitionIdentificationPurityE 261 POTASSIUM ACETATEDefinitionIdentificationPurityE 262 (i) SODIUM ACETATEDefinitionIdentificationPurityE 262 (ii) SODIUM DIACETATEIdentificationPurityE 263 CALCIUM ACETATEDefinitionIdentificationPurityE 270 LACTIC ACIDDefinitionIdentificationPurityE 280 PROPIONIC ACIDDefinitionIndentificationPurityE 281 SODIUM PROPIONATEDefinitionIdentificationPurityE 282 CALCIUM PROPIONATEDefinitionIdentificationPurityE 283 POTASSIUM PROPIONATEDefinitionIdentificationPurityE 284 BORIC ACIDDefinitionIdentificationPurityE 285 SODIUM TETRABORATE (BORAX)DefinitionIdentificationPurityE 290 CARBON DIOXIDEDefinitionIdentificationPurityE 300 ASCORBIC ACIDDefinitionIdentificationPurityE 301 SODIUM ASCORBATEDefinitionIdentificationPurityE 302 CALCIUM ASCORBATEDefinitionIdentificationPurityE 304 (i) ASCORBYL PALMITATEDefinitionIdentificationPurityE 304 (ii) ASCORBYL STEARATEDefinitionIdentificationPurityE 306 TOCOPHEROL-RICH EXTRACTIdentificationPurityE 307 ALPHA-TOCOPHEROLDefinitionIdentificationPurityE 308 GAMMA-TOCOPHEROLDefinitionIdentificationPurityE 309 DELTA-TOCOPHEROLDefinitionIdentificationPurityE 310 PROPYL GALLATEDefinitionIdentificationPurityE 311 OCTYL GALLATEDefinitionIdentificationPurityE 312 DODECYL GALLATEDefinitionIdentificationPurityE 315 ERYTHORBIC ACIDDefinitionIdentificationPurityE 316 SODIUM ERYTHORBATEDefinitionIdentificationPurityE 320 BUTYLATED HYDROXYANISOLE (BHA)DefinitionIdentificationPurityE 321 BUTYLATED HYDROXYTOLUENE (BHT)DefinitionIdentificationPurityE 322 LECITHINSIdentificationPurityE 325 SODIUM LACTATEDefinitionIdentificationPurityE 326 POTASSIUM LACTATEDefinitionIdentificationPurityE 327 CALCIUM LACTATEDefinitionIdentificationPurityE 330 CITRIC ACIDDefinitionIdentificationPurityE 331 (i) MONOSODIUM CITRATEDefinitionIdentificationPurityE 331 (ii) DISODIUM CITRATEDefinitionIdentificationPurityE 331 (iii) TRISODIUM CITRATEDefinitionIdentificationPurityE 332 (i) MONOPOTASSIUM CITRATEDefinitionIdentificationPurityE 332 (ii) TRIPOTASSIUM CITRATEDefinitionIdentificationPurityE 333 (i) MONOCALCIUM CITRATEDefinitionIdentificationPurityE 333 (ii) DICALCIUM CITRATEDefinitionIdentificationPurityE 333 (iii) TRICALCIUM CITRATEDefinitionIdentificationPurityE 334 L(+)-TARTARIC ACIDDefinitionIdentificationPurityE 335 (i) MONOSODIUM TARTRATEDefinitionIdentificationPurityE 335 (ii) DISODIUM TARTRATEDefinitionIdentificationPurityE 336 (i) MONOPOTASSIUM TARTRATEDefinitionIdentificationPurityE 336 (ii) DIPOTASSIUM TARTRATEDefinitionIdentificationPurityE 337 POTASSIUM SODIUM TARTRATEDefinitionIdentificationPurityE 338 PHOSPHORIC ACIDDefinitionIdentificationPurityE 339 (i) MONOSODIUM PHOSPHATEDefinitionIdentificationPurityE 339 (ii) DISODIUM PHOSPHATEDefinitionIdentificationPurityE 339 (iii) TRISODIUM PHOSPHATEIdentificationPurityE 340 (i) MONOPOTASSIUM PHOSPHATEDefinitionIdentificationPurityE 340 (ii) DIPOTASSIUM PHOSPHATEDefinitionIdentificationPurityE 340 (iii) TRIPOTASSIUM PHOSPHATEDefinitionIdentificationPurityE 341 (i) MONOCALCIUM PHOSPHATEDefinitionIdentificationPurityE 341 (ii) DICALCIUM PHOSPHATEDefinitionIdentificationPurityE 341 (iii) TRICALCIUM PHOSPHATEIdentificationPurityE 385 CALCIUM DISODIUM ETHYLENEDIAMINETETRAACETATEDefinitionIdentificationPurityE 400 ALGINIC ACIDIdentificationPurityE 401 SODIUM ALGINATEDefinitionIdentificationPurityE 402 POTASSIUM ALGINATEDefinitionIdentificationPurityE 403 AMMONIUM ALGINATEDefinitionIdentificationPurityE 404 CALCIUM ALGINATEDefinitionIdentificationPurityE 405 PROPANE-1,2-DIOL ALGINATEDefinitionIdentificationPurityE 406 AGARDefinitionIdentificationPurityE 407 CARRAGEENANIdentificationPurityE 407a PROCESSED EUCHEUMA SEAWEEDIdentificationPurityE 410 LOCUST BEAN GUMIdentificationPurityE 412 GUAR GUMIdentificationPurityE 413 TRAGACANTHIdentificationPurityE 414 ACACIA GUMIdentificationPurityE 415 XANTHAN GUMIdentificationPurityE 416 KARAYA-GUMIdentificationPurityE 417 TARA GUMIdentificationPurityE 418 GELLAN GUMIdentificationPurityE 422 GLYCEROLDefinitionIdentificationPurityE 431 POLYOXYETHYLENE (40) STEARATEIdentificationPurityE 432 POLYOXYETHYLENE SORBITAN MONOLAURATE (POLYSORBATE 20)IdentificationPurityE 433 POLYOXYETHYLENE SORBITAN MONOOLEATE (POLYSORBATE 80)IdentificationPurityE 434 POLYOXYETHYLENE SORBITAN MONOPALMITATE (POLYSORBATE 40)IdentificationPurityE 435 POLYOXYETHYLENE SORBITAN MONOSTEARATE (POLYSORBATE 60)IdentificationPurityE 436 POLYOXYETHYLENE SORBITAN TRISTEARATE (POLYSORBATE 65)IdentificationPurityE 440 (i) PECTINIdentificationPurityE 440 (ii) AMIDATED PECTINIdentificationPurityE 442 AMMONIUM PHOSPHATIDESIdentificationPurityE 444 SUCROSE ACETATE ISOBUTYRATEIdentificationPurityE 445 GLYCEROL ESTERS OF WOOD ROSINIdentificationPurityE 450 (i) DISODIUM DIPHOSPHATEDefinitionIdentificationPurityE 450 (ii) TRISODIUM DIPHOSPHATEDefinitionIdentificationPurityE 450 (iii) TETRASODIUM DIPHOSPHATEDefinitionIdentificationPurityE 450 (v) TETRAPOTASSIUM DIPHOSPHATEDefinitionIdentificationPurityE 450 (vi) DICALCIUM DIPHOSPHATEDefinitionIdentificationPurityE 450 (vii) CALCIUM DIHYDROGEN DIPHOSPHATEDefinitionIdentificationPurityE 451 (i) PENTASODIUM TRIPHOSPHATEDefinitionIdentificationPurityE 451 (ii) PENTAPOTASSIUM TRIPHOSPHATEDefinitionIdentificationPurityE 452 (i) SODIUM POLYPHOSPHATE1.SOLUBLE POLYPHOSPHATEIdentificationPurity2.INSOLUBLE POLYPHOSPHATEIIdentificationPurityE 452 (ii) POTASSIUM POLYPHOSPHATEDefinitionIdentificationPurityE 452 (iv) CALCIUM POLYPHOSPHATEDefinitionIdentificationPurityE 460 (i) MICROCRISTALLINE CELLULOSEIdentificationPurityE 460 (ii) POWDERED CELLULOSEIdentificationPurityE 461 METHYL CELLULOSEIdentificationPurityE 463 HYDROXYPROPYL CELLULOSEIdentificationPurityE 464 HYDROXYPROPYL METHYL CELLULOSEIdentificationPurityE 465 ETHYL METHYL CELLULOSEIdentificationPurityE 466 SODIUM CARBOXY METHYL CELLULOSEIdentificationPurityE 470a SODIUM, POTASSIUM AND CALCIUM SALTS OF FATTY ACIDSIdentificationPurityE 470b MAGNESIUM SALTS OF FATTY ACIDSIdentificationPurityE 471 MONO- AND DIGLYCERIDES OF FATTY ACIDSIdentificationPurityE 472 a ACETIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDSIdentificationPurityE 472 b LACTIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDSIdentificationPurityE 472 c CITRIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDSIdentificationPurityE 472 d TARTARIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDSIdentificationPurityE 472 e MONO- AND DIACETYLTARTARIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDSIdentificationPurityE 472 f MIXED ACETIC AND TARTARIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDSIdentificationPurityE 473 SUCROSE ESTERS OF FATTY ACIDSIdentificationPurityE 474 SUCROGLYCERIDESIdentificationPurityE 475 POLYGLYCEROL ESTERS OF FATTY ACIDSIdentificationPurityE 476 POLYGLYCEROL POLYRICINOLEATEIdentificationPurityE 477 PROPANE-1,2-DIOL ESTERS OF FATTY ACIDSIdentificationPurityE 479 b THERMALLY OXIDISED SOYA BEAN OIL INTERACTED WITH MONO- AND DIGLYCERIDES OF FATTY ACIDSIdentificationPurityE 481 SODIUM STEAROYL-2-LACTYLATEIdentificationPurityE 482 CALCIUM STEAROYL-2-LACTYLATEIdentificationPurityE 483 STEARYL TARTRATEIdentificationPurityE 491 SORBITAN MONOSTEARATEIdentificationPurityE 492 SORBITAN TRISTEARATEIdentificationPurityE 493 SORBITAN MONOLAURATEIdentificationPurityE 494 SORBITAN MONOOLEATEIdentificationPurityE 495 SORBITAN MONOPALMITATEIdentificationPurityE 508 POTASSIUM CHLORIDEDefinitionIdentificationPurityE 579 FERROUS GLUCONATEDefinitionIdentificationPurityE 585 FERROUS LACTATEDefinitionIdentificationPurityE 650 ZINC ACETATEDefinitionIdentificationPurityE 943a BUTANEDefinitionIdentificationPurityE 943b ISOBUTANEDefinitionIdentificationPurityE 944 PROPANEDefinitionIdentificationPurityE 949 HYDROGENDefinitionPurityE 1105 LYSOZYMEIdentificationPurityMicrobiological criteriaE 1201 POLYVINYLPYRROLIDONEDefinitionIdentificationPurityE 1202 POLYVINYLPOLYPYRROLIDONEIdentificationPurityPOLYETHYLENE GLYCOL 6000IdentificationPurityE 296 MALIC ACIDDefinitionIdentificationPurityE 297 FUMARIC ACIDDefinitionIdentificationPurityE 343(i) MONOMAGNESIUM PHOSPHATEDefinitionIdentificationPurityE 343(ii) DIMAGNESIUM PHOSPHATEDefinitionIdentificationPurityE 350 (i) SODIUM MALATEDefinitionIdentificationPurityE 350 (ii) SODIUM HYDROGEN MALATEDefinitionIdentificationPurityE 351 POTASSIUM MALATEDefinitionIdentificationPurityE 352 (i) CALCIUM MALATEDefinitionIdentificationPurityE 352 (ii) CALCIUM HYDROGEN MALATEDefinitionIdentificationPurityE 355 ADIPIC ACIDDefinitionIdentificationPurityE 363 SUCCINIC ACIDDefinitionIdentificationPurityE 380 TRIAMMONIUM CITRATEDefinitionIdentificationPurityE 452(iii) SODIUM CALCIUM POLYPHOSPHATEDefinitionIdentificationPurityE 459 BETA-CYCLODEXTRINIdentificationPurityE 468 CROSS-LINKED SODIUM CARBOXYMETHYLCELLULOSEIdentificationPurityE 469 ENZYMATICALLY HYDROLYSED CARBOXYMETHYLCELLULOSEIdentificationPurityE 500(i) SODIUM CARBONATEDefinitionIdentificationPurityE 500(ii) SODIUM HYDROGEN CARBONATEDefinitionIdentificationPurityE 500(iii) SODIUM SESQUICARBONATEDefinitionIdentificationPurityE 501(i) POTASSIUM CARBONATEDefinitionIdentificationPurityE 501(ii) POTASSIUM HYDROGEN CARBONATEDefinitionIdentificationPurityE 503(i) AMMONIUM CARBONATEIdentificationPurityE 503(ii) AMMONIUM HYDROGEN CARBONATEDefinitionIdentificationPurityE 507 HYDROCHLORIC ACIDDefinitionIdentificationPurityE 509 CALCIUM CHLORIDEDefinitionIdentificationPurityE 511 MAGNESIUM CHLORIDEDefinitionIdentificationPurityE 512 STANNOUS CHLORIDEDefinitionIdentificationPurityE 513 SULPHURIC ACIDDefinitionIdentificationPurityE 514(i) SODIUM SULPHATEDefinitionIdentificationPurityE 514(ii) SODIUM HYDROGEN SULPHATEDefinitionIdentificationPurityE 515(i) POTASSIUM SULPHATEDefinitionIdentificationPurityE 515(ii) POTASSIUM HYDROGEN SULPHATEDefinitionIdentificationPurityE 516 CALCIUM SULPHATEDefinitionIdentificationPurityE 517 AMMONIUM SULPHATEDefinitionIdentificationPurityE 520 ALUMINIUM SULPHATEDefinitionIdentificationPurityE 521 ALUMINIUM SODIUM SULPHATEDefinitionIdentificationPurityE 522 ALUMINIUM POTASSIUM SULPHATEDefinitionIdentificationPurityE 523 ALUMINIUM AMMONIUM SULPHATEDefinitionIdentificationPurityE 524 SODIUM HYDROXIDEDefinitionIdentificationPurityE 525 POTASSIUM HYDROXIDEDefinitionIdentificationPurityE 526 CALCIUM HYDROXIDEDefinitionIdentificationPurityE 527 AMMONIUM HYDROXIDEDefinitionIdentificationPurityE 528 MAGNESIUM HYDROXIDEDefinitionIdentificationPurityE 529 CALCIUM OXIDEDefinitionIdentificationPurityE 530 MAGNESIUM OXIDEDefinitionIdentificationPurityE 535 SODIUM FERROCYANIDEDefinitionIdentificationPurityE 536 POTASSIUM FERROCYANIDEDefinitionIdentificationPurityE 538 CALCIUM FERROCYANIDEDefinitionIdentificationPurityE 541 SODIUM ALUMINIUM PHOSPHATE, ACIDICDefinitionIdentificationPurityE 551 SILICON DIOXIDEIdentificationPurityE 552 CALCIUM SILICATEIdentificationPurityE 553a(i) MAGNESIUM SILICATEIdentificationPurityE 553a(ii) MAGNESIUM TRISILICATEDefinitionIdentificationPurityE 570 FATTY ACIDSIdentificationPurityE 574 GLUCONIC ACIDIdentificationPurityE 575 GLUCONO-DELTA-LACTONEIdentificationPurityE 576 SODIUM GLUCONATEDefinitionIdentificationPurityE 577 POTASSIUM GLUCONATEDefinitionIdentificationPurityE 578 CALCIUM GLUCONATEDefinitionIdentificationPurityE 640 GLYCINE AND ITS SODIUM SALTDefinitionIdentificationPurityE 900 DIMETHYL POLYSILOXANEIdentificationPurityE 901 BEESWAXIdentificationPurityE 902 CANDELILLA WAXIdentificationPurityE 903 CARNAUBA WAXIdentificationPurityE 904 SHELLACIdentificationPurityE 920 L-CYSTEINEIdentificationPurityE 927b CARBAMIDEDefinitionIdentificationPurityE 938 ARGONDefinitionPurityE 939 HELIUMDefinitionPurityE 941 NITROGENDefinitionPurityE 942 NITROUS OXIDEDefinitionPurityE 948 OXYGENDefinitionPurityE 999 QUILLAIA EXTRACTIdentificationPurityE 1103 INVERTASEPurityE 1200 POLYDEXTROSEIdentificationPurityE 1404 OXIDISED STARCHIdentificationPurity (all values expressed on an anhydrous basis except for loss on drying)E 1410 MONOSTARCH PHOSPHATEIdentificationPurity (all values expressed on an anhydrous basis except for loss on drying)E 1412 DISTARCH PHOSPHATEIdentificationPurity (all values expressed on an anhydrous basis except for loss on drying)E 1413 PHOSPHATED DISTARCH PHOSPHATEIdentificationPurity (all values expressed on an anhydrous basis except for loss on drying)E 1414 ACETYLATED DISTARCH PHOSPHATEIdentificationPurity (all values expressed on an anhydrous basis except for loss on drying)E 1420 ACETYLATED STARCHIdentificationPurity (all values expressed on an anhydrous basis except for loss on drying)E 1422 ACETYLATED DISTARCH ADIPATEIdentificationPurity (all values expressed on an anhydrous basis except for loss on drying)E 1440 HYDROXYPROPYL STARCHIdentificationPurity (all values expressed on an anhydrous basis except for loss on drying)E 1442 HYDROXYPROPYL DISTARCH PHOSPHATEIdentificationPurity (all values expressed on an anhydrous basis except for loss on drying)E 1450 STARCH SODIUM OCTENYL SUCCINATEIdentificationPurity (all values expressed on an anhydrous basis except for loss on drying)E 1451 ACETYLATED OXIDISED STARCHIdentificationPurity (all values expressed on an anhydrous basis except for loss on drying)E 1505 TRIETHYL CITRATEDefinitionIdentificationPurityE 1518 GLYCERYL TRIACETATEDefinitionIdentificationPurityE 1520 PROPANE-1,2-DIOLDefinitionIdentificationPurity
Chemical nameSorbic acidTrans, trans-2,4-hexadienoic acid
Einecs203-768-7
Chemical formulaC6H8O2
Molecular weight112,12
AssayContent not less than 99 % on the anhydrous basis
DescriptionColourless needles or white free flowing powder, having a slight characteristic odour and showing no change in colour after heating for 90 minutes at 105 °C
A. Melting rangeBetween 133 °C and 135 °C, after vacuum drying for four hours in a sulphuric acid desiccator
B. SpectrometryAn isopropanol solution (1 in 4000000) shows absorbance maximum at 254 ± 2 nm
C. Positive test for double bonds
D. Sublimation point80 °C
Water contentNot more than 0,5 % (Karl Fischer method)
Sulphated ashNot more than 0,2 %
AldehydesNot more than 0,1 % (as formaldehyde)
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Chemical namePotassium sorbatePotassium (E,E)-2,4-hexadienoatePotassium salt of trans, trans 2,4-hexadienoic acid
Einecs246-376-1
Chemical formulaC6H7O2K
Molecular weight150,22
AssayContent not less than 99 % on the dried basis
DescriptionWhite crystalline powder showing no change in colour after heating for 90 minutes at 105 °C
A. Melting range of sorbic acid isolated by acidification and not recrystallized 133 °C to 135 °C after vacuum drying in a sulphuric acid desiccator
B. Positive tests for potassium and for double bonds
Loss on dryingNot more than 1,0 % (105 °C, 3h)
Acidity or alkalinityNot more than about 1,0 % (as sorbic acid or K2CO3)
AldehydesNot more than 0,1 %, calculated as formaldehyde
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Chemical nameCalcium sorbateCalcium salts of trans, trans-2,4-hexadienoic acid
Einecs231-321-6
Chemical formulaC12H14O4Ca
Molecular weight262,32
AssayContent not less than 98 % on the dried basis
DescriptionFine white crystalline powder not showing any change in colour after heating at 105 °C for 90 minutes
A. Melting range of sorbic acid isolated by acidification and not recrystallized 133 °C to 135 °C after vacuum drying in a sulphuric acid desiccator
B. Positive tests for calcium and for double bonds
Loss on dryingNot more than 2,0 %, determined by vacuum drying for four hours in a sulphuric acid desiccator
AldehydesNot more than 0,1 % (as formaldehyde)
FluorideNot more than 10 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Chemical nameBenzoic acidBenzenecarboxylic acidPhenylcarboxylic acid
Einecs200-618-2
Chemical formulaC7H6O2
Molecular weight122,12
AssayContent not less than 99,5 % on the anhydrous basis
DescriptionWhite crystalline powder
A. Melting range121,5 °C to 123,5 °C
B. Positive sublimation test and test for benzoate
Loss on dryingNot more than 0,5 % after drying for three hours over sulphuric acid
pHAbout 4 (solution in water)
Sulphated ashNot more than 0,05 %
Chlorinated organic compoundsNot more than 0,07 % expressed as chloride corresponding to 0,3 % expressed as monochlorobenzoic acid
Readily oxidizable substancesAdd 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4 in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required
Readily carbonizable substancesA cold solution of 0,5 g of benzoic acid in 5 ml of 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of ferric chloride TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of water
Polycyclic acidsOn fractional acidification of a neutralized solution of benzoic acid, the first precipitate must not have a different melting point from that of the benzoic acid
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Chemical nameSodium benzoateSodium salt of benzenecarboxylic acidSodium salt of phenylcarboxylic acid
Einecs208-534-8
Chemical formulaC7H5O2Na
Molecular weight144,11
AssayNot less than 99 % of C7H5O2Na, after drying at 105 °C for four hours
DescriptionA white, almost odourless, crystalline powder or granules
A. SolubilityFreely soluble in water, sparingly soluble in ethanol
B. Melting range for benzoic acidMelting range of benzoic acid isolated by acidification and not recrystallized 121,5 °C to 123,5 °C, after drying in a sulphuric acid desiccator
C. Positive tests for benzoate and for sodium
Loss on dryingNot more than 1,5 % after drying at 105 °C for four hours
Readily oxidizable substancesAdd 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4 in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required
Polycyclic acidsOn fractional acidification of a (neutralized) solution of sodium benzoate, the first precipitate must not have a different melting range from that of benzoic acid
Chlorinated organic compoundsNot more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monochlorobenzoic acid
Degree of acidity or alkalinityNeutralization of 1 g of sodium benzoate, in the presence of phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Chemical namePotassium benzoatePotassium salt of benzenecarboxylic acidPotassium salt of phenylcarboxylic acid
Einecs209-481-3
Chemical formulaC7H5KO2·3H2O
Molecular weight214,27
AssayContent not less than 99 % C7H5O2K after drying at 105 °C to constant weight
DescriptionWhite crystalline powder
A. Melting range of benzoic acid isolated by acidification and not recrystallized 121,5 °C to 123,5 °C, after vacuum drying in a sulphuric acid desiccator
B. Positive tests for benzoate and for potassium
Loss on dryingNot more than 26,5 %, determined by drying at 105 °C
Chlorinated organic compoundsNot more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monochlorobenzoic acid
Readily oxidizable substancesAdd 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4 in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required
Readily carbonizable substancesA cold solution of 0,5 g of benzoic acid in 5 ml 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of ferric chloride TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of water
Polycyclic acidsOn fractional acidification of a (neutralized) solution of potassium benzoate, the first precipitate must not have a different melting range from that of benzoic acid
Degree of acidity or alkalinityNeutralization of 1 g of potassium benzoate, in the presence of phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
SynonymsMonocalcium benzoate
Chemical nameCalcium benzoateCalcium dibenzoate
Einecs218-235-4
Chemical formulaAnhydrous:C14H10O4Ca
Monohydrate:C14H10O4Ca·H2O
Trihydrate:C14H10O4CA·3H2O
Molecular weightAnhydrous:282,31
Monohydrate:300,32
Trihydrate:336,36
AssayContent not less than 99 % after drying at 105 °C
DescriptionWhite or colourless crystals, or white powder
A. Melting range of benzoic acid isolated by acidification and not recrystallized 121,5 °C to 123,5 °C, after vacuum drying in a sulphuric acid desiccator
B. Positive tests for benzoate and for calcium
Loss on dryingNot more than 17,5 % determined by drying at 105 °C to constant weight
Water insoluble matterNot more than 0,3 %
Chlorinated organic compoundsNot more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monochlorobenzoic acids
Readily oxidizable substancesAdd 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4 in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required
Readily carbonizable substancesCold solution of 0,5 g of benzoic acid in 5 ml of 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of ferric chloride TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of water
Polycyclic acidsOn fractional acidification of a (neutralized) solution of calcium benzoate, the first precipitate must not be a different melting range from that of benzoic acid
Degree of acidity or alkalinityNeutralization of 1 g of calcium benzoate, in the presence of phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl
FluorideNot more than 10 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
SynonymsEthylparabenEthyl p-oxybenzoate
Chemical nameEthyl-p-hydroxybenzoateEthyl ester of p-hydroxybenzoic acid
Einecs204-399-4
Chemical formulaC9H10O3
Molecular weight166,8
AssayContent not less than 99,5 % after drying for two hours at 80 °C
DescriptionAlmost odourless, small, colourless crystals or a white, crystalline powder
A. Melting range115 °C to 118 °C
B. Positive test for p-hydroxybenzoateMelting range of p-hydroxybenzoic acid isolated by acidification and not recrystallized: 213 °C to 217 °C, after vacuum drying in a sulphuric acid desiccator
C. Positive test for alcohol
Loss on dryingNot more than 0,5 % after drying for two hours at 80 °C
Sulphated ashNot more than 0,05 %
p-Hydroxybenzoic acid and salicylic acidNot more than 0,35 % expressed as p-hydroxybenzoic acid
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Chemical nameSodium ethyl p-hydroxybenzoateSodium compound of the ethyl ester of p-hydroxybenzoic acid
Einecs252-487-6
Chemical formulaC9H9O3Na
Molecular weight188,8
AssayContent of ethylester of p-hydroxybenzoic acid not less than 83 % on the anhydrous basis
DescriptionWhite, crystalline hygroscopic powder
A. Melting range115 °C to 118 °C, after vacuum drying in a sulphuric acid desiccator
B. Positive test for p-hydroxybenzoateMelting range of p-hydroxybenzoic acid derived from the sample is 213 °C to 217 °C
C. Positive test for sodium
D. pH of a 0,1 % aqueous solution must be between 9,9 and 10,3
Loss on dryingNot more than 5 %, determined by vacuum drying in a sulphuric acid desiccator
Sulphated ash37 to 39 %
p-Hydroxybenzoic acid and salicylic acidNot more than 0,35 % expressed as p-hydroxybenzoic acid
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
SynonymsPropylparabenPropyl p-oxybenzoate
Chemical namePropyl p-hydroxybenzoaten-Propyl p-hydroxybenzoic acid
Einecs202-307-7
Chemical formulaC10H12O3
Molecular weight180,21
AssayContent not less than 99,5 % after drying for two hours at 80 °C
DescriptionAlmost odourless, small, colourless crystals or a white, crystalline powder
A. Melting range95 °C to 97 °C after drying for two hours at 80 °C
B. Positive test for p-hydroxybenzoateMelting range of p-hydroxybenzoic acid derived from the sample is 213 °C to 217 °C
Loss on dryingNot more than 0,5 % after drying for two hours at 80 °C
Sulphated ashNot more than 0,05 %
p-Hydroxybenzoic acid and salicylic acidNot more than 0,35 % expressed as p-hydroxybenzoic acid
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Chemical nameSodium n-propyl p-hydroxybenzoateSodium compound of the n-propylester of p-hydroxybenzoic acid
Einecs252-488-1
Chemical formulaC10H11O3Na
Molecular weight202,21
AssayContent of the propyl ester of p-hydroxybenzoic acid not less than 85 % on the anhydrous basis
DescriptionWhite, or almost white, crystalline hygroscopic powder
A. Melting range of ester isolated by acidification and not recrystallized: 94 °C to 97 °C, after vacuum drying in a sulphuric acid desiccator
B. Positive test for sodium
C. pH of a 0,1 % aqueous solution must be between 9,8 and 10,2
Loss on dryingNot more than 5 %, determined by vacuum drying in a sulphuric acid desiccator
Sulphated ash34 to 36 %
p-Hydroxybenzoic acid and salicylic acidNot more than 0,35 % expressed as p-hydroxybenzoic acid
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
SynonymsMethylparabenMethyl-p-oxybenzoate
Chemical nameMethyl p-hydroxybenzoateMethyl ester of p-hydroxybenzoic acid
Einecs243-171-5
Chemical formulaC8H8O3
Molecular weight152,15
AssayContent not less than 99 % after drying for two hours at 80 °C
DescriptionAlmost odourless, small colourless crystals or white crystalline powder
A. Melting range125 °C to 128 °C
B. Positive test for p-hydroxybenzoateMelting range of p-hydroxybenzoic acid derived from the sample is 213 °C to 217 °C after drying for two hours at 80 °C
Loss on dryingNot more than 0,5 %, after drying for two hours at 80 °C
Sulphated ashNot more than 0,05 %
p-Hydroxybenzoic acid and salicylic acidNot more than 0,35 % expressed as p-hydroxybenzoic acid
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Chemical nameSodium methyl p-hydroxybenzoateSodium compound of the methylester of p-hydroxybenzoic acid
Chemical formulaC8H7O3Na
Molecular weight174,15
AssayContent not less than 99,5 % on the anhydrous basis
DescriptionWhite, hygroscopic powder
A. The white precipitate formed by acidifying with hydrochloric acid a 10 % (w/v) aqueous solution of the sodium derivative of methyl p-hydroxybenzoate (using litmus paper as indicator) shall, when washed with water and dried at 80 °C for two hours, have a melting range of 125 °C to 128 °C
B. Positive test for sodium
C. pH of a 0,1 % solution in carbon dioxide free water, not less than 9,7 and not more than 10,3
Water contentNot more than 5 % (Karl Fischer method)
Sulphated ash40 % to 44,5 % on the anhydrous basis
p-Hydroxybenzoic acid and salicylic acidNot more than 0,35 % expressed as p-hydroxybenzoic acid
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Chemical nameSulphur dioxideSulphurous acid anhydride
Einecs231-195-2
Chemical formulaSO2
Molecular weight64,07
AssayContent not less than 99 %
DescriptionColourless, non-flammable gas with strong pungent suffocating odour
A. Positive test for sulphurous substances
Water contentNot more than 0,05 %
Non-volatile residueNot more than 0,01 %
Sulphur trioxideNot more than 0,1 %
SeleniumNot more than 10 mg/kg
Other gases not normally present in the airNo trace
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Chemical nameSodium sulphite (anhydrous or heptahydrate)
Einecs231-821-4
Chemical formulaAnhydrous:Na2SO3
Heptahydrate:Na2SO37H2O
Molecular weightAnhydrous:126,04
Heptahydrate:252,16
AssayAnhydrous:Not less than 95 % of Na2SO3 and not less than 48 % of SO2
Heptahydrate:Not less than 48 % of Na2SO3 and not less than 24 % of SO2
DescriptionWhite crystalline powder or colourless crystals
A. Positive tests for sulphite and for sodium
B. pH of a 10 % solution (anhydrous) or a 20 % solution (heptahydrate) between 8,5 and 11,5
ThiosulphateNot more than 0,1 % based on the SO2 content
IronNot more than 50 mg/kg based on the SO2 content
SeleniumNot more than 10 mg/kg based on the SO2 content
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Chemical nameSodium bisulphiteSodium hydrogen sulphite
Einecs231-921-4
Chemical formulaNaHSO3 in aqueous solution
Molecular weight104,06
AssayContent not less than 32 % w/w NaHSO3
DescriptionA clear, colourless to yellow solution
A. Positive tests for sulphite and for sodium
B. pH of a 10 % aqueous solution between 2,5 and 5,5
IronNot more than 50 mg/kg of Na2SO3 based on the SO2 content
SeleniumNot more than 10 mg/kg based on the SO2 content
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
SynonymsPyrosulphiteSodium pyrosulphite
Chemical nameSodium disulphiteDisodium pentaoxodisulphate
Einecs231-673-0
Chemical formulaNa2S2O5
Molecular weight190,11
AssayContent not less than 95 % Na2S2O5 and not less than 64 % of SO2
DescriptionWhite crystals or crystalline powder
A. Positive tests for sulphite and for sodium
B. pH of a 10 % aqueous solution between 4,0 and 5,5
ThiosulphateNot more than 0,1 % based on the SO2 content
IronNot more than 50 mg/kg based on the SO2 content
SeleniumNot more than 10 mg/kg based on the SO2 content
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
SynonymsPotassium pyrosulphite
Chemical namePotassium disulphitePotassium pentaoxo disulphate
Einecs240-795-3
Chemical formulaK2S2O5
Molecular weight222,33
AssayContent not less than 90 % of K2S2O5 and not less than 51,8 % of SO2, the remainder being composed almost entirely of potassium sulphate
DescriptionColourless crystals or white crystalline powder
A. Positive tests for sulphite and for potassium
ThiosulphateNot more than 0,1 % based on the SO2 content
IronNot more than 50 mg/kg based on the SO2 content
SeleniumNot more than 10 mg/kg based on the SO2 content
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Chemical nameCalcium sulphite
Einecs218-235-4
Chemical formulaCaSO3·2H2O
Molecular weight156,17
AssayContent not less than 95 % of CaSO3·2H2O and not less than 39 % of SO2
DescriptionWhite crystals or white crystalline powder
A. Positive tests for sulphite and for calcium
IronNot more than 50 mg/kg based on the SO2 content
SeleniumNot more than 10 mg/kg based on the SO2 content
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Chemical nameCalcium bisulphiteCalcium hydrogen sulphite
Einecs237-423-7
Chemical formulaCa(HSO3)2
Molecular weight202,22
Assay6 to 8 % (w/v) of sulphur dioxide and 2,5 to 3,5 % (w/v) of calcium dioxide corresponding to 10 to 14 % (w/v) of calcium bisulphite [Ca(HSO3)2]
DescriptionClear greenish-yellow aqueous solution having a distinct odour of sulphur dioxide
A. Positive tests for sulphite and for calcium
IronNot more than 50 mg/kg based on the SO2 content
SeleniumNot more than 10 mg/kg based on the SO2 content
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Chemical namePotassium bisulphitePotassium hydrogen sulphite
Einecs231-870-1
Chemical formulaKHSO3 in aqueous solution
Molecular weight120,17
AssayContent not less than 280 g KHSO3 per litre (or 150 g SO2 per litre)
DescriptionClear colourless aqueous solution
A. Positive tests for sulphite and for potassium
IronNot more than 50 mg/kg based on the SO2 content
SeleniumNot more than 10 mg/kg based on the SO2 content
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
SynonymsDiphenyl
Chemical name1,1′-biphenylPhenylbenzene
Einecs202-163-5
Chemical formulaC12H10
Molecular weight154,20
AssayContent not less than 99,8 %
DescriptionWhite or pale yellow to amber crystalline solid having a characteristic odour
A. Melting range68,5 °C to 70,5 °C
B. Distillation rangeIt distils completely within a 2,5 °C range between 252,5 °C and 257,5 °C
BenzeneNot more than 10 mg/kg
Aromatic aminesNot more than 2 mg/kg (as aniline)
Phenol derivativesNot more than 5 mg/kg (as phenol)
Readily carbonizable substancesCold solution of 0,5 g of biphenyl in 5 ml of 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of ferric chloride TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of water
Terphenyl and higher polyphenyl derivativesNot more than 0,2 %
Polycyclic aromatic hydrocarbonsAbsent
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
SynonymsOrthoxenol
Chemical name(1,1'-Biphenyl)-2-ol2-Hydroxydiphenylo-Hydroxydiphenyl
Einecs201-993-5
Chemical formulaC12H10O
Molecular weight170,20
AssayContent not less than 99 %
DescriptionWhite or slightly yellowish crystalline powder
A. Melting range56 °C to 58 °C
B. Positive test for phenolateAn ethanolic solution (1 g in 10 ml) produces a green colour on addition of 10 % ferric chloride solution
Sulphated ashNot more than 0,05 %
Diphenyl etherNot more than 0,3 %
p-PhenylphenolNot more than 0,1 %
1-NaphtholNot more than 0,01 %
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
SynonymsSodium orthophenylphenateSodium salt of o-phenylphenol
Chemical nameSodium orthophenylphenol
Einecs205-055-6
Chemical formulaC12H9ONa·4H2O
Molecular weight264,26
AssayContent not less than 97 % of C12H9ONa·4H2O
DescriptionWhite or slightly yellowish crystalline powder
A. Positive tests for phenolate and for sodium
B. Melting range of orthophenylphenol isolated by acidification and not recrystallized derived from the sample 56 °C to 58 °C after drying in a sulphuric acid desiccator
C. pH of a 2 % aqueous solution must be between 11,1 and 11,8
DiphenyletherNot more than 0,3 %
p-phenylphenolNot more than 0,1 %
1-naphtholNot more than 0,01 %
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Chemical name4-(2-benzimidazolyl)thiazole2-(4-thiazolyl)-1H-benzimidazole
Einecs1205-725-8
Chemical formulaC10H7N3S
Molecular weight201,26
AssayContent not less than 98 % on the anhydrous basis
DescriptionWhite, or almost white, odourless powder
A. Melting range296 °C to 303 °C
B. SpectrometryAbsorption maxima in 0,1 N HCl (0,0005 % w/v) at 302 nm, 258 nm and 243 nmE 1 cm1 % at 302 nm ± 2 nm: approximately 1230E 1 cm1 % at 258 nm ± 2 nm: approximately 200E 1 cm1 % at 243 nm ± 2 nm: approximately 620Ratio of absorption 243 nm/302 nm = 0,47 to 0,53Ratio of absorption 258 nm/302 nm = 0,14 to 0,18
Water contentNot more than 0,5 % (Karl Fischer method)
Sulphated ashNot more than 0,2 %
SeleniumNot more than 3 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
DefinitionNisin consists of several closely related polypeptides produced by natural strains of Streptococcus lactis, Lancefield group N
Einecs215-807-5
Chemical formulaC143H230N42O37S7
Molecular weight3354,12
AssayNisin concentrate contains not less than 900 units per mg in a mixture of non-fat milk solids and a minimum sodium chloride content of 50 %
DescriptionWhite powder
Loss on dryingNot more than 3 % when dried to constant weight at 102 °C to 103 °C
ArsenicNot more than 1 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
SynonymsPimaricin
DefinitionNatamycin is a fungicide of the polyene macrolide group, and is produced by natural strains of Streptomyces natalensis or of Streptococcus lactis
Einecs231-683-5
Chemical formulaC33H47O13N
Molecular weight665,74
AssayContent not less than 95 % on the anhydrous basis
DescriptionWhite to creamy-white crystalline powder
A. Colour reactionsOn adding a few crystals of natamycin on a spot plate, to a drop of:concentrated hydrochloric acid, a blue colour develops,concentrated phosphoric acid, a green colour develops,which changes into pale red after a few minutes
B. SpectrometryA 0,0005 % w/v solution in 1 % methanolic acetic acid solution has absorption maxima at about 290 nm, 303 nm and 318 nm, a shoulder at about 280 nm and exhibits minima at about 250 nm, 295,5 nm and 311 nm
C. pH5,5 to 7,5 (1 % w/v solution in previously neutralized mixture of 20 parts dimethylformamide and 80 parts of water)
D. Specific rotationαD20+ 250 °to + 295 ° (a 1 % w/v solution in glacial acetic acid, at 20 °C and calculated with reference to the dried material)
Loss on dryingNot more than 8 % (over P2O5, in vacuum at 60 °C to constant weight)
Sulphated ashNot more than 0,5 %
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Microbiological criteria: total viable countNot more than 100/g
SynonymsHexamineMethenamine
Chemical name1,3,5,7-Tetraazatricyclo [3.3.1.13,7]-decane, hexamethylenetetramine
Einecs202-905-8
Chemical formulaC6H12N4
Molecular weight140,19
AssayContent not less than 99 % on the anhydrous basis
DescriptionColourless or white crystalline powder
A. Positive tests for formaldehyde and for ammonia
B. Sublimation point approximately 260 °C
Loss on dryingNot more than 0,5 % after drying at 105 °C in vacuum over P2O5 for two hours
Sulphated ashNot more than 0,05 %
SulphatesNot more than 0,005 % expressed as SO4
ChloridesNot more than 0,005 % expressed as Cl
Ammonium saltsNot detectable
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
SynonymsDMDCDimethyl pyrocarbonate
Einecs224-859-8
Chemical nameDimethyl dicarbonatePyrocarbonic acid dimethyl ester
Chemical formulaC4H6O5
Molecular weight134,09
AssayContent not less than 99,8 %
DescriptionColourless liquid, decomposes in aqueous solution. It is corrosive to skin and eyes and toxic by inhalation and ingestion
A. DecompositionAfter dilution positive tests for CO2 and methanol
B. Melting pointBoiling point17 °C172 °C with decomposition
C. Density 20 °CApproximately 1,25 g/cm3
D. Infrared spectrumMaxima at 1156 and 1832 cm− 1
Dimethyl carbonateNot more than 0,2 %
Chlorine, totalNot more than 3 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Chemical namePotassium nitrite
Einecs231-832-4
Chemical formulaKNO2
Molecular weight85,11
AssayContent not less than 95 % on the anhydrous basis
DescriptionWhite or slightly yellow, deliquescent granules
A. Positive tests for nitrite and for potassium
B. pH of a 5 % solution: not less than 6,0 and not more than 9,0
Loss on dryingNot more than 3 % after drying for four hours over silica gel
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Chemical nameSodium nitrite
Einecs231-555-9
Chemical formulaNaNO2
Molecular weight69,00
AssayContent not less than 97 % on the anhydrous basis
DescriptionWhite crystalline powder or yellowish lumps
A. Positive tests for nitrite and for sodium
Loss on dryingNot more than 0,25 % after drying over silica gel for four hours
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
SynonymsChile saltpetre
Cubic or soda nitre
Chemical nameSodium nitrate
EINECS231-554-3
Chemical formulaNaNO3
Molecular weight85,00
AssayContent not less than 99 % after drying
DescriptionWhite crystalline, slightly hygroscopic powder
A.Positive tests for nitrate and for sodium
B.pH of a 5 % solutionNot less than 5,5 and not more than 8,3
Loss on dryingNot more than 2 % after drying at 105 °C for four hours
NitritesNot more than 30 mg/kg expressed as NaNO2
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
DefinitionLiquid sodium nitrate is an aqueous solution of sodium nitrate as the direct result of the chemical reaction between sodium hydroxide and nitric acid in stoechiometric amounts, without subsequent crystallisation. Standardised forms prepared from liquid sodium nitrate meeting these specifications may contain nitric acid in excessive amounts, if clearly stated or labelled.
Chemical nameSodium nitrate
EINECS231-554-3
Chemical formulaNaNO3
Molecular weight85,00
AssayContent between 33,5 % and 40,0 % of NaNO3
DescriptionClear colourless liquid
A.Positive tests for nitrate and for sodium
B.pHNot less than 1,5 and not more than 3,5
Free nitric acidNot more than 0,01 %
NitritesNot more than 10 mg/kg expressed as NaNO2
ArsenicNot more than 1 mg/kg
LeadNot more than 1 mg/kg
MercuryNot more than 0,3 mg/kg
This specification refers to a 35 % aqueous solution.
SynonymsChile saltpetreCubic or soda nitre
Chemical namePotassium nitrate
Einecs231-818-8
Chemical formulaKNO3
Molecular weight101,11
AssayContent not less than 99 % on the anhydrous basis
DescriptionWhite crystalline powder or transparent prisms having a cooling, saline, pungent taste
A. Positive tests for nitrate and for potassium
B. pH of a 5 % solutionNot less than 4,5 and not more than 8,5
Loss on dryingNot more than 1 % after drying at 105 °C for four hours
NitritesNot more than 20 mg/kg expressed as KNO2
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Chemical nameAcetic acidEthanoic acid
Einecs200-580-7
Chemical formulaC2H4O2
Molecular weight60,05
AssayContent not less than 99,8 %
DescriptionClear, colourless liquid having a pungent, characteristic odour
A. Boiling point118 °C at 760 mm pressure (of mercury)
B. Specific gravityAbout 1,049
C. A one in three solution gives positive tests for acetate
D. Solidification pointNot lower than 14,5 °C
Non-volatile residueNot more than 100 mg/kg
Formic acid, formates and other oxidizable substancesNot more than 1000 mg/kg expressed as formic acid
Readily oxidizable substancesDilute 2 ml of the sample in a glass-stoppered container with 10 ml of water and add 0,1 ml of 0,1 N potassium permanganate. The pink colour does not change to brown within 30 minutes
ArsenicNot more than 1 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Chemical namePotassium acetate
Einecs204-822-2
Chemical formulaC2H3O2K
Molecular weight98,14
AssayContent not less than 99 % on the anhydrous basis
DescriptionColourless, deliquescent crystals or a white crystalline powder, odourless or with a faint acetic odour
A. pH of a 5 % aqueous solutionNot less than 7,5 and not more than 9,0
B. Positive tests for acetate and for potassium
Loss on dryingNot more than 8 % after drying at 150 °C for two hours
Formic acid, formates and other oxidizable substancesNot more than 1000 mg/kg expressed as formic acid
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Chemical nameSodium acetate
Einecs204-823-8
Chemical formulaC2H3NaO2·nH2O (n = 0 or 3)
Molecular weightAnhydrous:82,03
Trihydrate:136,08
AssayContent (for both of anhydrous and trihydrate form) not less than 98,5 % on the anhydrous basis
DescriptionAnhydrous:White, odourless, granular, hygroscopic powder
Trihydrate:Colourless, transparent crystals or a granular crystalline powder, odourless or with a faint, acetic odour. Effloresces in warm, dry air
A. pH of a 1 % aqueous solutionNot less than 8,0 and not more than 9,5
B. Positive tests for acetate and for sodium
Loss on dryingAnhydrous:Not more than 2 % (120 °C, 4 hours)
Trihydrate:Between 36 and 42 % (120 °C, 4 hours)
Formic acid, formates and other oxidizable substancesNot more than 1000 mg/kg expressed as formic acid
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
DefinitionSodium diacetate is a molecular compound of sodium acetate and acetic acid
Chemical nameSodium hydrogen diacetate
Einecs204-814-9
Chemical formulaC4H7NaO4·nH2O (n = 0 or 3)
Molecular weight142,09 (anhydrous)
AssayContent 39 to 41 % of free acetic acid and 58 to 60 % of sodium acetate
DescriptionWhite, hygroscopic crystalline solid with an acetic odour
A. pH of a 10 % aqueous solutionNot less than 4,5 and not more than 5,0
B. Positive tests for acetate and for sodium
Water contentNot more than 2 % (Karl Fischer method)
Formic acid, formates and other oxidizable substancesNot more than 1000 mg/kg expressed as formic acid
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Chemical nameCalcium acetate
Einecs200-540-9
Chemical formulaAnhydrous:C4H6O4Ca
Monohydrate:C4H6O4Ca·H2O
Molecular weightAnhydrous:158,17
Monohydrate:176,18
AssayContent not less than 98 % on the anhydrous basis
DescriptionAnhydrous calcium acetate is a white, hygroscopic, bulky, crystalline solid with a slightly bitter taste. A slight odour of acetic acid may be present. The monohydrate may be needles, granules or powder
A. pH of a 10 % aqueous solutionNot less than 6,0 and not more than 9,0
B. Positive tests for acetate and for calcium
Loss on dryingNot more than 11 % after drying (155 °C to constant weight, for the monohydrate)
Water insoluble matterNot more than 0,3 %
Formic acid, formates and other oxidizable substancesNot more than 1000 mg/kg expressed as formic acid
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Chemical nameLactic acid2-Hydroxypropionic acid1-Hydroxyethane-1-carboxylic acid
Einecs200-018-0
Chemical formulaC3H6O3
Molecular weight90,08
AssayContent not less than 76 % and not more than 84 %
DescriptionColourless or yellowish, nearly odourless, syrupy liquid with an acid taste, consisting of a mixture of lactic acid (C3H6O3) and lactic acid lactate (C6H10O5). It is obtained by the lactic fermentation of sugars or is prepared synthetically
Note:Lactic acid is hygroscopic and when concentrated by boiling, it condenses to form lactic acid lactate, which on dilution and heating hydrolyzes to lactic acid
A. Positive test for lactate
Sulphated ashNot more than 0,1 %
ChlorideNot more than 0,2 %
SulphateNot more than 0,25 %
IronNot more than 10 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Note:This specification refers to a 80 % aqueous solution; for weaker aqueous solutions, calculate values corresponding to their lactic acid content
Chemical namePropionic acidPropanoic acid
Einecs201-176-3
Chemical formulaC3H6O2
Molecular weight74,08
AssayContent not less than 99,5 %
DescriptionColourless or slightly yellowish, oily liquid with a slightly pungent odour
A. Melting point− 22 °C
B. Distillation range138,5 °C to 142,5 °C
Non-volatile residueNot more than 0,01 % when dried at 140 °C to constant weight
AldehydesNot more than 0,1 % expressed as formaldehyde
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Chemical nameSodium propionateSodium propanoate
Einecs205-290-4
Chemical formulaC3H5O2Na
Molecular weight96,06
AssayContent not less than 99 % after drying for two hours at 105 °C
DescriptionWhite crystalline hygroscopic powder, or a fine white powder
A. Positive tests for propionate and for sodium
B. pH of a 10 % aqueous solutionNot less than 7,5 and not more than 10,5
Loss on dryingNot more than 4 % determined by drying for two hours at 105 °C
Water insolublesNot more than 0,1 %
IronNot more than 50 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Chemical nameCalcium propionate
Einecs223-795-8
Chemical formulaC6H10O4Ca
Molecular weight186,22
AssayContent not less than 99 %, after drying for two hours at 105 °C
DescriptionWhite crystalline powder
A. Positive tests for propionate and for calcium
B. pH of a 10 % aqueous solutionBetween 6,0 and 9,0
Loss on dryingNot more than 4 %, determined by drying for two hours at 105 °C
Water insolublesNot more than 0,3 %
IronNot more than 50 mg/kg
FluorideNot more than 10 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Chemical namePotassium propionatePotassium propanoate
Einecs206-323-5
Chemical formulaC3H5KO2
Molecular weight112,17
AssayContent not less than 99 % after drying for two hours at 105 °C
DescriptionWhite crystalline powder
A. Positive tests for propionate and for potassium
Loss on dryingNot more than 4 %, determined by drying for two hours at 105 °C
Water-insoluble substancesNot more than 0,3 %
IronNot more than 30 mg/kg
FluorideNot more than 10 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
SynonymsBoracic acidOrthoboric acidBorofax
Einecs233-139-2
Chemical formulaH3BO3
Molecular weight61,84
AssayContent not less than 99,5 %
DescriptionColourless, odourless, transparent crystals or white granules or powder; slightly unctuous to the touch; occurs in nature as the mineral sassolite
A. Melting pointAt approximately 171 °C
B. Burns with a nice green flame
C. pH of a 3,3 % aqueous solutionBetween 3,8 and 4,8
PeroxidesNo colour develops with added KI-solution
ArsenicNot more than 1 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
SynonymsSodium borate
Chemical nameSodium tetraborateSodium biborateSodium pyroborateAnhydrous tetraborate
Einecs215-540-4
Chemical formulaNa2B4O7Na2B4O7·10H2O
Molecular weight201,27
DescriptionPowder or glass-like plates becoming opaque on exposure to air; slowly soluble in water
A. Melting rangeBetween 171 °C and 175 °C with decomposition
PeroxidesNo colour develops with added KI-solution
ArsenicNot more than 1 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
SynonymsCarbonic acid gasDry ice (solid form)Carbonic anhydride
Chemical nameCarbon dioxide
Einecs204-696-9
Chemical formulaCO2
Molecular weight44,01
AssayContent not less than 99 % v/v on the gaseous basis
DescriptionA colourless gas under normal environmental conditions with a slight pungent odour. Commercial carbon dioxide is shipped and handled as a liquid in pressurized cylinders or bulk storage systems, or in compressed solid blocks of "dry ice". Solid (dry ice) forms usually contain added substances, such as propylene glycol or mineral oil, as binders
A. Precipitation(Precipitate formation)When a stream of the sample is passed through a solution of barium hydroxide, a white precipitate is produced which dissolves with effervescence in dilute acetic acid
Acidity915 ml of gas bubbled through 50 ml of freshly boiled water must not render the latter more acid to methylorange than is 50 ml freshly boiled water to which has been added 1 ml of hydrochloric acid (0,01 N)
Reducing substances, hydrogen phosphide and sulphide915 ml of gas bubbled through 25 ml of ammoniacal silver nitrate reagent to which has been added 3 ml of ammonia must not cause clouding or blackening of this solution
Carbon monoxideNot more than 10 μl/l
Oil contentNot more than 0,1 mg/l
Chemical nameL-ascorbic acidAscorbic acid2,3-Didehydro-L-threo-hexono-1,4-lactone3-Keto-L-gulofuranolactone
Einecs200-066-2
Chemical formulaC6H8O6
Molecular weight176,13
AssayAscorbic acid, after drying in a vacuum desiccator over sulphuric acid for 24 hours, contains not less than 99 % of C6H8O6
DescriptionWhite to pale yellow, odourless crystalline solid
A. Melting rangeBetween 189 °C and 193 °C with decomposition
B. Positive tests for ascorbic acid
Loss on dryingNot more than 0,4 % after drying in a vacuum desiccator over sulphuric acid for 24 hours
Sulphated ashNot more than 0,1 %
Specific rotationαD20 between + 20,5 ° and + 21,5 ° (10 % w/v aqueous solution)
pH of a 2 % aqueous solutionBetween 2,4 and 2,8
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Chemical nameSodium ascorbateSodium L-ascorbate2,3-Didehydro-L-threo-hexono-1,4-lactone sodium enolate3-Keto-L-gulofurano-lactone sodium enolate
Einecs205-126-1
Chemical formulaC6H7O6Na
Molecular weight198,11
AssaySodium ascorbate, after drying in a vacuum desiccator over sulphuric acid for 24 hours, contains not less than 99 % of C6H7O6Na
DescriptionWhite or almost white, odourless crystalline solid which darkens on exposure to light
A. Positive tests for ascorbate and for sodium
Loss on dryingNot more than 0,25 % after drying in a vacuum desiccator over sulphuric acid for 24 hours
Specific rotationαD20 between + 103 ° and + 106 ° (10 % w/v aqueous solution)
pH of 10 % aqueous solutionBetween 6,5 and 8,0
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Chemical nameCalcium ascorbate dihydrateCalcium salt of 2,3-didehydro-L-threo-hexono-1,4-lactone dihydrate
Einecs227-261-5
Chemical formulaC12H14O12Ca·2H2O
Molecular weight426,35
AssayContent not less than 98 % on a volatile matter-free basis
DescriptionWhite to slightly pale greyish-yellow odourless crystalline powder
A. Positive tests for ascorbate and for calcium
FluorideNot more than 10 mg/kg (expressed as fluorine)
Specific rotationαD20 between + 95 ° and + 97 ° (5 % w/v aqueous solution)
pH of 10 % aqueous solutionBetween 6,0 and 7,5
Volatile matterNot more than 0,3 % determined by drying at room temperature for 24 hours in a desiccator containing sulphuric acid or phosphorus pentoxide
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Chemical nameAscorbyl palmitateL-ascorbyl palmitate2,3-didehydro-L-threo-hexono-1,4-lactone-6-palmitate6-palmitoyl-3-keto-L-gulofuranolactone
Einecs205-305-4
Chemical formulaC22H38O7
Molecular weight414,55
AssayContent not less than 98 % on the dried basis
DescriptionWhite or yellowish-white solid with a citrus-like odour
A. Melting rangeBetween 107 °C and 117 °C
Loss on dryingNot more than 2,0 % after drying in a vacuum oven at 56 °C and 60 °C for one hour
Sulphated ashNot more than 0,1 %
Specific rotationαD20 between + 21 °and + 24 ° (5 % w/v in methanol solution)
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Chemical nameAscorbyl stearateL-ascorbyl stearate2,3-didehydro-L-threo-hexono-1,4-lactone-6-stearate6-stearoyl-3-keto-L-gulofuranolactone
Einecs246-944-9
Chemical formulaC24H42O7
Molecular weight442,6
AssayContent not less than 98 %
DescriptionWhite or yellowish, white solid with a citrus-like odour
A. Melting pointAbout 116 °C
Loss on dryingNot more than 2,0 % after drying in a vacuum oven at 56 °C to 60 °C for one hour
Sulphated ashNot more than 0,1 %
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
DefinitionProduct obtained by the vacuum steam distillation of edible vegetable oil products, comprising concentrated tocopherols and tocotrienolsContains tocopherols such as d-α-, d-β-, d-γ- and d-ς-tocopherols
Molecular weight430,71 (d-α-tocopherol)
AssayContent not less than 34 % of total tocopherols
DescriptionBrownish red to red, clear, viscous oil having a mild, characteristic odour and taste. May show a slight separation of wax-like constituents in microcrystalline form
A. By suitable gas liquid chromatographic method
B. Solubility testsInsoluble in water. Soluble in ethanol. Miscible in ether
Sulphated ashNot more than 0,1 %
Specific rotationαD20 not less than + 20 °
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Synonymsdl-α-Tocopherol
Chemical namedl-5,7,8-Trimethyltocoldl-2,5,7,8-tetramethyl-2-(4′,8′12′-trimethyltridecyl)-6-chromanol
Einecs200-412-2
Chemical formulaC29H50O2
Molecular weight430,71
AssayContent not less than 96 %
DescriptionSlightly yellow to amber, nearly odourless, clear, viscous oil which oxidizes and darkens on exposure to air or light
A. Solubility testsInsoluble in water, freely soluble in ethanol, miscible in ether
B. SpectrophotometryIn absolute ethanol the maximum absorption is about 292 nm
Refractive indexn D201,5031,507
Specific absorptionE 1 cm1 % in ethanolE 1 cm1 %(292 nm) 72—76(0,01 g in 200 ml of absolute ethanol)
Sulphated ashNot more than 0,1 %
Specific rotationαD20 0 ° ± 0,05 ° (1 in 10 solution in chloroform)
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Synonymsdl-γ-Tocopherol
Chemical name2,7,8-trimethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol
Einecs231-523-4
Chemical formulaC28H48O2
Molecular weight416,69
AssayContent not less than 97 %
DescriptionClear, viscous, pale yellow oil which oxidizes and darkens on exposure to air or light
A. SpectrometryMaximum absorptions in absolute ethanol at about 298 nm and 257 nm
Specific absorptionE 1 cm1 % in ethanolE 1 cm1 % (298 nm) between 91 and 97E 1 cm1 % (257 nm) between 5,0 and 8,0
Refractive indexn D201,5031,507
Sulphated ashNot more than 0,1 %
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Chemical name2,8-dimethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol
Einecs204-299-0
Chemical formulaC27H46O2
Molecular weight402,7
AssayContent not less than 97 %
DescriptionClear, viscous, pale yellowish or orange oil which oxidizes and darkens on exposure to air or light
A. SpectrometryMaximum absorptions in absolute ethanol at about 298 nm and 257 nm
Specific absorptionE 1 cm1 % in ethanolE 1 cm1 % (298 nm) between 89 and 95E 1 cm1 % (257 nm) between 3,0 and 6,0
Refractive indexn D201,5001,504
Sulphated ashNot more than 0,1 %
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Chemical namePropyl gallatePropyl ester of gallic acidn-propyl ester of 3,4,5-trihydroxybenzoic acid
Einecs204-498-2
Chemical formulaC10H12O5
Molecular weight212,20
AssayContent not less than 98 % on the anhydrous basis
DescriptionWhite to creamy-white, crystalline, odourless solid
A. Solubility testsSlightly soluble in water, freely soluble in ethanol, ether and propane-1,2-diol
B. Melting rangeBetween 146 °C and 150 °C after drying at 110 °C for four hours
Loss on dryingNot more than 1,0 % (110 °C, four hours)
Sulphated ashNot more than 0,1 %
Free acidNot more than 0,5 % (as gallic acid)
Chlorinated organic compoundNot more than 100 mg/kg (as C1)
Specific absorptionE 1 cm1 % in ethanolE 1 cm1 % (275 nm) not less than 485 and not more than 520
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Chemical nameOctyl gallateOctyl ester of gallic acidn-octyl ester of 3,4,5-trihydroxybenzoic acid
Einecs213-853-0
Chemical formulaC15H22O5
Molecular weight282,34
AssayContent not less than 98 % after drying at 90 °C for six hours
DescriptionWhite to creamy-white odourless solid
A. Solubility testsInsoluble in water, freely soluble in ethanol, ether and propane-1,2-diol
B. Melting rangeBetween 99 °C and 102 °C after drying at 90 °C for six hours
Loss on dryingNot more than 0,5 % (90 °C, six hours)
Sulphated ashNot more than 0,05 %
Free acidNot more than 0,5 % (as gallic acid)
Chlorinated organic compoundNot more than 100 mg/kg (as C1)
Specific absorptionE 1 cm1 % in ethanolE 1 cm1 % (275 nm) not less than 375 and not more than 390
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
SynonymsLauryl gallate
Chemical nameDodecyl gallaten-dodecyl (or lauryl) ester of 3,4,5-trihydroxybenzoic acidDodecyl ester of gallic acid
Einecs214-620-6
Chemical formulaC19H30O5
Molecular weight338,45
AssayContent not less than 98 % after drying at 90 °C for six hours
DescriptionWhite or creamy-white odourless solid
A. Solubility testsInsoluble in water, freely soluble in ethanol and ether
B. Melting rangeBetween 95 °C and 98 °C after drying at 90 °C for six hours
Loss on dryingNot more than 0,5 % (90 °C, six hours)
Sulphated ashNot more than 0,05 %
Free acidNot more than 0,5 % (as gallic acid)
Chlorinated organic compoundNot more than 100 mg/kg (as Cl)
Specific absorptionE 1 cm1 % in ethanolE 1 cm1 % (275 nm) not less than 300 and not more than 325
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 30 mg/kg
SynonymsIsoascorbic acidD-araboascorbic acid
Chemical nameD-Erythro-hex-2-enoic acid γ-lactoneIsoascorbic acidD-isoascorbic acid
Einecs201-928-0
Chemical formulaC6H8O6
Molecular weight176,13
AssayContent not less than 98 % on the anhydrous basis
DescriptionWhite to slightly yellow crystalline solid which darkens gradually on exposure to light
A. Melting rangeAbout 164 °C to 172 °C with decomposition
B. Positive test for ascorbic acid/colour reaction
Loss on dryingNot more than 0,4 % after drying under reduced pressure on silica gel for 3 hours
Sulphated ashNot more than 0,3 %
Specific rotationαD25 10 % (w/v) aqueous solution between − 16,5 ° to − 18,0 °
OxalateTo a solution of 1 g in 10 ml of water add 2 drops of glacial acetic acid and 5 ml of 10 % calcium acetate solution. The solution should remain clear
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
SynonymsSodium isoascorbate
Chemical nameSodium isoascorbateSodium D-isoascorbic acidSodium salt of 2,3-didehydro-D-erythro-hexono-1,4-lactone3-keto-D-gulofurano-lactone sodium enolate monohydrate
Einecs228-973-9
Chemical formulaC6H7O6Na·H2O
Molecular weight216,13
AssayContent not less than 98 % after drying in a vacuum desiccator over sulphuric acid for 24 hours expressed on the monohydrate basis
DescriptionWhite crystalline solid
A. Solubility testsFreely soluble in water, very slightly soluble in ethanol
B. Positive test for ascorbic acid/colour reaction
C. Positive test for sodium
Loss on dryingNot more than 0,25 % after drying in a vacuum desiccator over sulphuric acid for 24 hours
Specific rotationαD25 10 % (w/v) aqueous solution between + 95 ° and + 98 °
pH of a 10 % aqueous solution5,5 to 8,0
OxalateTo a solution of 1 g in 10 ml of water add 2 drops of glacial acetic acid and 5 ml of 10 % calcium acetate solution. The solution should remain clear
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
SynonymsBHA
Chemical names3-Tertiary-butyl-4-hydroxyanisoleA mixture of 2-tertiary-butyl-4-hydroxyanisole and 3-tertiary-butyl-4-hydroxyanisole
EINECS246-563-8
Chemical formula
C11H16O2
Formula weight180,25
AssayContent not less than 98,5 % ofC11H16O2 and not less than 85 % of 3-tertiary-butyl-4-hydroxyanisole isomer
DescriptionWhite or slightly yellow crystals or waxy solid with a slight aromatic smell
A.SolubilityInsoluble in water, freely soluble in ethanol
B.Melting rangeBetween 48 °C and 63 °C
C.Colour reactionPasses test for phenol groups
Sulphated ashNot more than 0,05 % after calcination at 800 ± 25 °C
Phenolic impuritiesNot more than 0,5 %
Specific absorptionE1cm1%E1cm1% (290 nm) not less than 190 and not more than 210
Specific absorptionE1cm1%E1cm1% (228 nm) not less than 326 and not more than 345
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
SynonymsBHT
Chemical name2,6-Ditertiary-butyl-p-cresol4-Methyl-2,6-ditertiarybutylphenol
Einecs204-881-4
Chemical formulaC15H24O
Molecular weight220,36
AssayContent not less than 99 %
DescriptionWhite, crystalline or flaked solid, odourless or having a characteristic faint aromatic odour
A. Solubility testsInsoluble in water and propane- 1,2-diolFreely soluble in ethanol
B. Melting pointAt 70 °C
C. Absorbance maximumThe absorption in the range 230 to 320 nm of a 2 cm layer of a 1 in 100000 solution in dehydrated ethanol exhibits a maximum only at 278 nm
Sulphated ashNot more than 0,005 %
Phenolic impuritiesNot more than 0,5 %
Specific absorptionE 1 cm1 % in ethanolE 1 cm1 % (278 nm) not less than 81 and not more than 88
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
SynonymsPhosphatidesPhospholipids
DefinitionLecithins are mixtures or fractions of phosphatides obtained by physical procedures from animal or vegetable foodstuffs; they also include hydrolysed products obtained through the use of harmless and appropriate enzymes. The final product must not show any signs of residual enzyme activityThe lecithins may be slightly bleached in aqueous medium by means of hydrogen peroxide. This oxidation must not chemically modify the lecithin phosphatides
Einecs232-307-2
AssayLecithins: not less than 60,0 % of substances insoluble in acetoneHydrolysed lecithins: not less than 56,0 % of substances insoluble in acetone
DescriptionLecithins: brown liquid or viscous semi-liquid or powderHydrolysed lecithins: light brown to brown viscous liquid or paste
A. Positive tests for choline, for phosphorus and fatty acids
B. Test for hydrolysed lecithinTo a 800 ml beaker add 500 ml of water (30 °C—35 °C). Then slowly add 50 ml of the sample with constant stirring. Hydrolysed lecithin will form a homogeneous emulsion. Non-hydrolysed lecithin will form a distinct mass of about 50 g
Loss on dryingNot more than 2,0 % determined by drying at 105 °C for one hour
Toluene-insoluble matterNot more than 0,3 %
Acid valueLecithins: not more than 35 mg of potassium hydroxide per gramHydrolysed lecithins: not more than 45 mg of potassium hydroxide per gram
Peroxide valueEqual to or less than 10
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Chemical nameSodium lactateSodium 2-hydroxypropanoate
Einecs200-772-0
Chemical formulaC3H5NaO3
Molecular weight112,06 (anhydrous)
AssayContent not less than 57 % and not more than 66 %
DescriptionColourless, transparent, liquidOdourless, or with a slight, characteristic odour
A. Positive test for lactate
B. Positive test for potassium
AcidityNot more than 0,5 % after drying expressed as lactic acid
pH of a 20 % aqueous solution6,5 to 7,5
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Reducing substancesNo reduction of Fehling's solution
Note:This specification refers to a 60 % aqueous solution
Cheminal namePotassium lactatePotassium 2-hydroxypropanoate
Einecs213-631-3
Chemical formulaC3H5O3K
Molecular weight128,17 (anhydrous)
AssayContent not less than 57 % and not more than 66 %
DescriptionSlightly viscous, almost odourless clear liquid. Odourless, or with a slight, characteristic odour
A. IgnitionIgnite potassium lactate solution to an ash. The ash is alkaline, and an effervescence occurs when acid is added
B. Colour reactionOverlay 2 ml of potassium lactate solution on 5 ml of a 1 in 100 solution of catechol in sulphuric acid. A deep red colour is produced at the zone of contact
C. Positive tests for potassium and for lactate
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
AcidityDissolve 1 g of potassium lactate solution in 20 ml of water, add 3 drops of phenolphthalein TS and titrate with 0,1 N sodium hydroxide. Not more than 0,2 ml should be required
Reducing substancesPotassium lactate solution shall not cause any reduction of Fehling's solution
Note:This specification refers to a 60 % aqueous solution
Chemical nameCalcium dilactateCalcium dilactate hydrate2-Hydroxypropanoic acid calcium salt
Einecs212-406-7
Chemical formula(C3H5O2)2 Ca·nH2O (n = 0—5)
Molecular weight218,22 (anhydrous)
AssayContent not less than 98 % on the anhydrous basis
DescriptionAlmost odourless, white crystalline powder or granules
A. Positive tests for lactate and for calcium
B. Solubility testsSoluble in water and practically insoluble in ethanol
Loss on dryingDetermined by drying at 120 °C for four hours:anhydrous: not more than 3,0 %with 1 molecule of water: not more than 8,0 %with 3 molecules of water: not more than 20,0 %with 4,5 molecules of water: not more than 27,0 %
AcidityNot more than 0,5 % of the dry matter expressed as lactic acid
FluorideNot more than 30 mg/kg (expressed as fluorine)
pH of a 5 % solutionBetween 6,0 and 8,0
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Reducing substancesNo reduction of Fehling's solution
Chemical nameCitric acid2-Hydroxy-1,2,3-propanetricarboxylic acidβ-Hydroxytricarballytic acid
Einecs201-069-1
Chemical formula(a)C6H8O7 (anhydrous)(b)C6H8O7·H2O (monohydrate)
Molecular weight(a)192,13 (anhydrous)(b)210,15 (monohydrate)
AssayCitric acid may be anhydrous or it may contain 1 molecule of water. Citric acid contains not less than 99,5 % of C6H8O7, calculated on the anhydrous basis
DescriptionCitric acid is a white or colourless, odourless, crystalline solid, having a strongly acid taste. The monohydrate effloresces in dry air
A. Solubility testsVery soluble in water; freely soluble in ethanol; soluble in ether
Water contentAnhydrous citric acid contains not more than 0,5 % water; citric acid monohydrate contains not more than 8,8 % water (Karl Fischer method)
Sulphated ashNot more than 0,05 % after calcination at 800 ± 25 °C
ArsenicNot more than 1 mg/kg
LeadNot more than 1 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 5 mg/kg
OxalatesNot more than 100 mg/kg, expressed as oxalic acid, after drying
Readily carbonizable substancesHeat 1 g of powdered sample with 10 ml of 98 % minimum sulphuric acid in a water bath at 90 °C in the dark for one hour. Not more than a pale brown colour should be produced (Matching Fluid K)
SynonymsMonosodium citrateMonobasic sodium citrate
Chemical nameMonosodium citrateMonosodium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid
Chemical formula(a)C6H7O7Na (anhydrous)(b)C6H7O7Na·H2O (monohydrate)
Molecular weight(a)214,11 (anhydrous)(b)232,23 (monohydrate)
AssayContent not less than 99 % on the anhydrous basis
DescriptionCrystalline white powder or colourless crystals
A. Positive tests for citrate and for sodium
Loss on dryingDetermined by drying at 180 °C for four hours:anhydrous: not more than 1,0 %monohydrate: not more than 8,8 %
OxalatesNot more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 1 % aqueous solutionBetween 3,5 and 3,8
ArsenicNot more than 1 mg/kg
LeadNot more than 1 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 5 mg/kg
SynonymsDisodium citrateDibasic sodium citrate
Chemical nameDisodium citrateDisodium salt of 2-hydroxy-1,2,3-propanetricarboxylic acidDisodium salt of citric acid with 1,5 molecules of water
Einecs205-623-3
Chemical formulaC6H6O7Na2·1,5H2O
Molecular weight263,11
AssayContent not less than 99 % on the anhydrous basis
DescriptionCrystalline white powder or colourless crystals
A. Positive tests for citrate and for sodium
Loss on dryingNot more than 13,0 % by drying at 180 °C for four hours
OxalatesNot more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 1 % aqueous solutionBetween 4,9 and 5,2
ArsenicNot more than 1 mg/kg
LeadNot more than 1 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 5 mg/kg
SynonymsTrisodium citrateTribasic sodium citrate
Chemical nameTrisodium citrateTrisodium salt of 2-hydroxy-1,2,3-propanetricarboxylic acidTrisodium salt of citric acid, in anhydrous, dihydrate or pentahydrate form
Einecs200-675-3
Chemical formulaAnhydrous:C6H5O7Na3
Hydrated:C6H5O7Na3·nH2O (n = 2 or 5)
Molecular weight258,07 (anhydrous)
AssayNot less than 99 % on the anhydrous basis
DescriptionCrystalline white powder or colourless crystals
A. Positive tests for citrate and for sodium
Loss on dryingDetermined by drying at 180 °C for four hours:
— anhydrous:not more than 1,0 %
— dihydrate:not more than 13,5 %
— pentahydrate:not more than 30,3 %
OxalatesNot more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 5 % aqueous solutionBetween 7,5 and 9,0
ArsenicNot more than 1 mg/kg
LeadNot more than 1 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 5 mg/kg
SynonymsMonopotassium citrateMonobasic potassium citrate
Chemical nameMonopotassium citrateMonopotassium salt of 2-hydroxy-1,2,3-propanetricarboxylic acidAnhydrous monopotassium salt of citric acid
Einecs212-753-4
Chemical formulaC6H7O7K
Molecular weight230,21
AssayContent not less than 99 % on the anhydrous basis
DescriptionWhite, hygroscopic, granular powder or transparent crystals
A. Positive tests for citrate and for potassium
Loss on dryingNot more than 1,0 % determined by drying at 180 °C for four hours
OxalatesNot more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 1 % aqueous solutionBetween 3,5 and 3,8
ArsenicNot more than 1 mg/kg
LeadNot more than 1 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 5 mg/kg
SynonymsTripotassium citrateTribasic potassium citrate
Chemical nameTripotassium citrateTripotassium salt of 2-hydroxy-1,2,3-propanetricarboxylic acidMonohydrated tripotassium salt of citric acid
Einecs212-755-5
Chemical formulaC6H5O7K3·H2O
Molecular weight324,42
AssayContent not less than 99 % on the anhydrous basis
DescriptionWhite, hygroscopic, granular powder or transparent crystals
A. Positive tests for citrate and for potassium
Loss on dryingNot more than 6,0 % determined by drying at 180 °C for four hours
OxalatesNot more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 5 % aqueous solutionBetween 7,5 and 9,0
ArsenicNot more than 1 mg/kg
LeadNot more than 1 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 5 mg/kg
SynonymsMonocalcium citrateMonobasic calcium citrate
Chemical nameMonocalcium citrateMonocalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acidMonohydrate monocalcium salt of citric acid
Chemical formula(C6H7O7)2Ca·H2O
Molecular weight440,32
AssayContent not less than 97,5 % on the anhydrous basis
DescriptionFine white powder
A. Positive tests for citrate and for calcium
Loss on dryingNot more than 7,0 % determined by drying at 180 °C for four hours
OxalatesNot more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 1 % aqueous solutionBetween 3,2 and 3,5
FluorideNot more than 30 mg/kg (expressed as fluorine)
ArsenicNot more than 1 mg/kg
LeadNot more than 1 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 5 mg/kg
CarbonatesDissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must not liberate more than a few isolated bubbles
SynonymsDicalcium citrateDibasic calcium citrate
Chemical nameDicalcium citrateDicalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acidTrihydrated dicalcium salt of citric acid
Chemical formula(C6H7O7)2Ca2·3H2O
Molecular weight530,42
AssayNot less than 97,5 % on the anhydrous basis
DescriptionFine white powder
A. Positive tests for citrate and for calcium
Loss on dryingNot more than 20,0 % determined by drying at 180 °C for four hours
OxalatesNot more than 100 mg/kg expressed as oxalic acid, after drying
FluorideNot more than 30 mg/kg (expressed as fluorine)
ArsenicNot more than 1 mg/kg
LeadNot more than 1 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 5 mg/kg
CarbonatesDissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must not liberate more than a few isolated bubbles
SynonymsTricalcium citrateTribasic calcium citrate
Chemical nameTricalcium citrateTricalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acidTetrahydrated tricalcium salt of citric acid
Einecs212-391-7
Chemical formula(C6H6O7)2Ca3·4H2O
Molecular weight570,51
AssayNot less than 97,5 % on the anhydrous basis
DescriptionFine white powder
A. Positive tests for citrate and for calcium
Loss on dryingNot more than 14,0 % determined by drying at 180 °C for four hours
OxalatesNot more than 100 mg/kg expressed as oxalic acid, after drying
FluorideNot more than 30 mg/kg (expressed as fluorine)
ArsenicNot more than 1 mg/kg
LeadNot more than 1 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 5 mg/kg
CarbonatesDissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must not liberate more than a few isolated bubbles
Chemical nameL-tartaric acidL-2,3-dihydroxybutanedioic acidd-α,β-dihydroxysuccinic acid
Einecs201-766-0
Chemical formulaC4H6O6
Molecular weight150,09
AssayContent not less than 99,5 % on the anhydrous basis
DescriptionColourless or translucent crystalline solid or white crystalline powder
A. Melting rangeBetween 168 °C and 170 °C
B. Positive test for tartrate
Loss on dryingNot more than 0,5 % (over P2O5, three hours)
Sulphated ashNot more than 1000 mg/kg after calcination at 800 ± 25 °C
Specific optical rotation of a 20 % w/v aqueous solutionαD20 between + 11,5 ° and + 13,5 °
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
OxalatesNot more than 100 mg/kg expressed as oxalic acid, after drying
SynonymsMonosodium salt of L-(+)-tartaric acid
Chemical nameMonosodium salt of L-2,3-dihydroxybutanedioic acidMonohydrated monosodium salt of L-(+)-tartaric acid
Chemical formulaC4H5O6Na·H2O
Molecular weight194,05
AssayContent not less than 99 % on the anhydrous basis
DescriptionTransparent colourless crystals
A. Positive tests for tartrate and for sodium
Loss on dryingNot more than 10,0 % determined by drying at 105 °C for four hours
OxalatesNot more than 100 mg/kg expressed as oxalic acid, after drying
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Chemical nameDisodium L-tartrateDisodium (+)-tartrateDisodium (+)-2,3-dihydroxybutanedioic acidDihydrated disodium salt of L-(+)-tartaric acid
Einecs212-773-3
Chemical formulaC4H4O6Na2·2H2O
Molecular weight230,8
AssayContent not less than 99 % on the anhydrous basis
DescriptionTransparent, colourless crystals
A. Positive tests for tartrate and for sodium
B. Solubility tests1 gram is insoluble in 3 ml of water. Insoluble in ethanol
Loss on dryingNot more than 17,0 % determined by drying at 150 °C for four hours
OxalatesNot more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 1 % aqueous solutionBetween 7,0 and 7,5
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
SynonymsMonobasic potassium tartrate
Chemical nameAnhydrous monopotassium salt of L-(+)-tartaric acidMonopotassium salt of L-2,3-dihydroxybutanedioic acid
Chemical formulaC4H5O6K
Molecular weight188,16
AssayContent not less than 98 % on the anhydrous basis
DescriptionWhite crystalline or granulated powder
A. Positive tests for tartrate and for potassium
B. Melting point230 °C
pH of a 1 % aqueous solution3,4
Loss on dryingNot more than 1,0 % determined by drying at 105 °C for four hours
OxalatesNot more than 100 mg/kg expressed as oxalic acid, after drying
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
SynonymsDibasic potassium tartrate
Chemical nameDipotassium salt of L-2,3-dihydroxybutanedioic acidDipotassium salt with half a molecule of water of L-(+)-tartaric acid
Einecs213-067-8
Chemical formulaC4H4O6K2·½H2O
Molecular weight235,2
AssayContent not less than 99 % on the anhydrous basis
DescriptionWhite crystalline or granulated powder
A. Positive tests for tartrate and for potassium
pH of a 1 % aqueous solutionBetween 7,0 and 9,0
Loss on dryingNot more than 4,0 % determined by drying at 150 °C for four hours
OxalatesNot more than 100 mg/kg expressed as oxalic acid, after drying
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
SynonymsPotassium sodium L-(+)-tartrateRochelle saltSeignette salt
Chemical namePotassium sodium salt of L-2,3-dihydroxybutanedioic acidPotassium sodium L-(+)-tartrate
Einecs206-156-8
Chemical formulaC4H4O6KNa·4H2O
Molecular weight282,23
AssayContent not less than 99 % on the anhydrous basis
DescriptionColourless crystals or white crystalline powder
A. Positive tests for tartrate, for potassium and for sodium
B. Solubility tests1 gram is soluble in 1 ml of water, insoluble in ethanol
C. Melting rangeBetween 70 and 80 °C
Loss on dryingNot more than 26,0 % and not less than 21,0 % determined by drying at 150 °C for three hours
OxalatesNot more than 100 mg/kg expressed as oxalic acid, after drying
pH of 1 % aqueous solutionBetween 6,5 and 8,5
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
SynonymsOrthophosphoric acidMonophosphoric acid
Chemical namePhosphoric acid
Einecs231-633-2
Chemical formulaH3PO4
Molecular weight98,00
AssayPhosphoric acid is commercially available as an aqueous solution at variable concentrations. Content not less than 67,0 % and not more than 85,7 %.
DescriptionClear, colourless, viscous liquid
A.Positive tests for acid and for phosphate
Volatile acidsNot more than 10 mg/kg (as acetic acid)
ChloridesNot more than 200 mg/kg (expressed as chlorine)
NitratesNot more than 5 mg/kg (as NaNO3)
SulphatesNot more than 1500 mg/kg (as CaSO4)
FluorideNot more than 10 mg/kg (expressed as fluorine)
ArsenicNot more than 3 mg/kg
CadmiumNot more than 1 mg/kg
LeadNot more than 4 mg/kg
MercuryNot more than 1 mg/kg
Note:This specification refers to a 75 % aqueous solution.
SynonymsMonosodium monophosphateAcid monosodium monophosphateMonosodium orthophosphateMonobasic sodium phosphateSodium dihydrogen monophosphate
Chemical nameSodium dihydrogen monophosphate
Einecs231-449-2
Chemical formulaAnhydrous: NaH2PO4Monohydrate: NaH2PO4 · H2ODihydrate: NaH2PO4 · 2H2O
Molecular weightAnhydrous: 119,98Monohydrate: 138,00Dihydrate: 156,01
AssayAfter drying at 60 °C for one hour and then at 105 °C for four hours, contains not less than 97 % of NaH2PO4
P2O5 contentBetween 58,0 % and 60,0 % on the anhydrous basis
DescriptionA white odourless, slightly deliquescent powder, crystals or granules
A.Positive tests for sodium and for phosphate
B.SolubilityFreely soluble in water. Insoluble in ethanol or ether
C.pH of a 1 % solutionBetween 4,1 and 5,0
Loss on dryingThe anhydrous salt loses not more than 2,0 %, the monohydrate not more than 15,0 %, and the dihydrate not more than 25 % when dried first at 60 °C for one hour, then at 105 °C for four hours
Water-insoluble substancesNot more than 0,2 % on the anhydrous basis
FluorideNot more than 10 mg/kg (expressed as fluorine)
ArsenicNot more than 3 mg/kg
CadmiumNot more than 1 mg/kg
LeadNot more than 4 mg/kg
MercuryNot more than 1 mg/kg
SynonymsDisodium monophosphateSecondary sodium phosphateDisodium orthophosphateAcid disodium phosphate
Chemical nameDisodium hydrogen monophosphateDisodium hydrogen orthophosphate
Einecs231-448-7
Chemical formulaAnhydrous: Na2HPO4Hydrat: Na2HPO4 · nH2O (n = 2, 7 or 12)
Molecular weight141,98 (anhydrous)
AssayAfter drying at 40 °C for three hours and subsequently at 105 °C for five hours, contains not less than 98 % of Na2HPO4
P2O5 contentBetween 49 % and 51 % on the anhydrous basis
DescriptionAnhydrous disodium hydrogen phosphate is a white, hygroscopic, odourless powder. Hydrated forms available include the dihydrate: a white crystalline, odourless solid; the heptahydrate: white, odourless, efflorescent crystals or granular powder; and the dodecahydrate: white, efflorescent, odourless powder or crystals
A.Positive tests for sodium and for phosphate
B.SolubilityFreely soluble in water. Insoluble in ethanol
C.pH of a 1 % solutionBetween 8,4 and 9,6
Loss on dryingWhen dried at 40 °C for three hours and then at 105°C for five hours, the losses in weight are as follows: anhydrous not more than 5,0 %, dihydrate not more than 22,0 %, heptahydrate not more than 50,0 %, dodecahydrate not more than 61,0 %
Water-insoluble substancesNot more than 0,2 % on the anhydrous basis
FluorideNot more than 10 mg/kg (expressed as fluorine)
ArsenicNot more than 3 mg/kg
CadmiumNot more than 1 mg/kg
LeadNot more than 4 mg/kg
MercuryNot more than 1 mg/kg
SynonymsSodium phosphateTribasic sodium phosphateTrisodium orthophosphate
DefinitionTrisodium phosphate is obtained from aqueous solutions and crystallises in the anhydrous form and with 1/2, 1, 6, 8 or 12 H2O. The dodecahydrate always crystallises from aqueous solutions with an excess of sodium hydroxide. It contains ¼ molecule of NaOH
Chemical nameTrisodium monophosphateTrisodium phosphateTrisodium orthophosphate
Einecs231-509-8
Chemical formulaAnhydrous: Na3PO4Hydrated: Na3PO4 · nH2O (n = 1/2, 1, 6, 8, or 12)
Molecular weight163,94 (anhydrous)
AssaySodium phosphate anhydrous and the hydrated forms, with the exception of the dodecahydrate, contain not less than 97,0 % of Na3PO4 calculated on the dried basis.Sodium phosphate dodecahydrate contains not less than 92,0 % of Na3PO4 calculated on the ignited basis
P2O5 contentBetween 40,5 % and 43,5 % on the anhydrous basis
DescriptionWhite odourless crystals, granules or crystalline powder
A.Positive tests for sodium and for phosphate
B.SolubilityFreely soluble in water. Insoluble in ethanol
C.pH of a 1 % solutionBetween 11,5 and 12,5
Loss on ignitionWhen dried at 120 °C for two hours and then ignited at about 800 °C for 30 minutes, the losses in weight are as follows: anhydrous not more than 2,0 %, monohydrate not more than 11,0 %, dodecahydrate: between 45,0 % and 58,0 %
Water insoluble substancesNot more than 0,2 % on the anhydrous basis
FluorideNot more than 10 mg/kg (expressed as fluorine)
ArsenicNot more than 3 mg/kg
CadmiumNot more than 1 mg/kg
LeadNot more than 4 mg/kg
MercuryNot more than 1 mg/kg
SynonymsMonobasic potassium phosphateMonopotassium monophosphatePotassium orthophosphate
Chemical namePotassium dihydrogen phosphateMonopotassium dihydrogen orthophosphateMonopotassium dihydrogen monophosphate
Einecs231-913-4
Chemical formulaKH2PO4
Molecular weight136,09
AssayContent not less than 98,0 % after drying at 105 °C for four hours
P2O5 contentBetween 51,0 % and 53,0 % on the anhydrous basis
DescriptionOdourless, colourless crystals or white granular or crystalline powder, hygroscopic
A.Positive tests for potassium and for phosphate
B.SolubilityFreely soluble in water. Insoluble in ethanol
C.pH of a 1 % solutionBetween 4,2 and 4,8
Loss on dryingNot more than 2,0 % determined by drying at 105 °C for four hours
Water-insoluble substancesNot more than 0,2 % on the anhydrous basis
FluorideNot more than 10 mg/kg (expressed as fluorine)
ArsenicNot more than 3 mg/kg
CadmiumNot more than 1 mg/kg
LeadNot more than 4 mg/kg
MercuryNot more than 1 mg/kg
SynonymsDipotassium monophosphateSecondary potassium phosphateDipotassium acid phosphateDipotassium orthophosphateDibasic potassium phosphate
Chemical nameDipotassium hydrogen monophosphateDipotassium hydrogen phosphateDipotassium hydrogen orthophosphate
Einecs231-834-5
Chemical formulaK2HPO4
Molecular weight174,18
AssayContent not less than 98 % after drying at 105°C for four hours
P2O5 contentBetween 40,3 % and 41,5 % on the anhydrous basis
DescriptionColourless or white granular powder, crystals or masses; deliquescent substance
A.Positive tests for potassium and for phosphate
B.SolubilityFreely soluble in water. Insoluble in ethanol
C.pH of a 1 % solutionBetween 8,7 and 9,4
Loss on dryingNot more than 2,0 % determined by drying at 105 °C for four hours
Water-insoluble substancesNot more than 0,2 % on the anhydrous basis
FluorideNot more than 10 mg/kg (expressed as fluorine)
ArsenicNot more than 3 mg/kg
CadmiumNot more than 1 mg/kg
LeadNot more than 4 mg/kg
MercuryNot more than 1 mg/kg
SynonymsPotassium phosphateTribasic potassium phosphateTripotassium orthophosphate
Chemical nameTripotassium monophosphateTripotassium phosphateTripotassium orthophosphate
Einecs231-907-1
Chemical formulaAnhydrous: K3PO4Hydrated: K3PO4 · nH2O (n = 1 or 3)
Molecular weight212,27 (anhydrous)
AssayContent not less than 97 % calculated on the ignited basis
P2O5 contentBetween 30,5 % and 33,0 % on the ignited basis
DescriptionColourless or white, odourless hygroscopic crystals or granules. Hydrated forms available include the monohydrate and trihydrate
A.Positive tests for potassium and for phosphate
B.SolubilityFreely soluble in water. Insoluble in ethanol
C.pH of a 1 % solutionBetween 11,5 and 12,3
Loss on ignitionAnhydrous: not more than 3,0 %; hydrated: not more than 23,0 %. Determined by drying at 105 °C for one hour and then ignite at about 800 °C ± 25 °C for 30 minutes
Water insoluble substancesNot more than 0,2 % on the anhydrous basis
FluorideNot more than 10 mg/kg (expressed as fluorine)
ArsenicNot more than 3 mg/kg
CadmiumNot more than 1 mg/kg
LeadNot more than 4 mg/kg
MercuryNot more than 1 mg/kg
SynonymsMonobasic calcium phosphateMonocalcium orthophosphate
Chemical nameCalcium dihydrogen phosphate
Einecs231-837-1
Chemical formulaAnhydrous: Ca(H2PO4)2Monohydrate: Ca(H2PO4)2 · H2O
Molecular weight234,05 (anhydrous)252,08 (monohydrate)
AssayContent not less than 95 % on the dried basis
P2O5 contentBetween 55,5 % and 61,1 % on the anhydrous basis
DescriptionGranular powder or white, deliquescent crystals or granules
A.Positive tests for calcium and for phosphate
B.CaO contentBetween 23,0 % and 27,5 % (anhydrous)Between 19,0 % and 24,8 % (monohydrate)
Loss on dryingNot more than 14 % determined by drying at 105 °C for four hours (anhydrous)Not more than 17,5 % determined by drying at 60 °C for one hour, then at 105 °C for four hours (monohydrate)
Loss on ignitionNot more than 17,5 % after ignition at 800 °C ± 25 °C for 30 minutes (anhydrous)Not more than 25,0 % determined by drying at 105 °C for one hour, then ignite at 800 °C ± 25 °C for 30 minutes (monohydrate)
FluorideNot more than 30 mg/kg (expressed as fluorine)
ArsenicNot more than 3 mg/kg
CadmiumNot more than 1 mg/kg
LeadNot more than 4 mg/kg
MercuryNot more than 1 mg/kg
SynonymsDibasic calcium phosphateDicalcium orthophosphate
Chemical nameCalcium monohydrogen phosphateCalcium hydrogen orthophosphateSecondary calcium phosphate
Einecs231-826-1
Chemical formulaAnhydrous: CaHPO4Dihydrate: CaHPO4 · 2H2O
Molecular weight136,06 (anhydrous)172,09 (dihydrate)
AssayDicalcium phosphate, after drying at 200 °C for three hours, contains not less than 98 % and not more than the equivalent of 102 % of CaHPO4
P2O5 contentBetween 50,0 % and 52,5 % on the anhydrous basis
DescriptionWhite crystals or granules, granular powder or powder
A.Positive tests for calcium and for phosphate
B.Solubility testsSparingly soluble in water. Insoluble in ethanol
Loss on ignitionNot more than 8,5 % (anhydrous), or 26,5 % (dihydrate) after ignition at 800 °C ± 25 °C for 30 minutes
FluorideNot more than 50 mg/kg (expressed as fluorine)
ArsenicNot more than 3 mg/kg
CadmiumNot more than 1 mg/kg
LeadNot more than 4 mg/kg
MercuryNot more than 1 mg/kg
SynonymsCalcium phosphate, tribasicCalcium orthophosphatePentacalcium hydroxy monophosphateCalcium hydroxyapatite
DefinitionTricalcium phosphate consists of a variable mixture of calcium phosphates obtained from neutralisation of phosphoric acid with calcium hydroxide and having the approximate composition of 10CaO · 3P2O5 · H2O
Chemical namePentacalcium hydroxy monophosphateTricalcium monophosphate
Einecs235-330-6 (Pentacalcium hydroxy monophosphate)231-840-8 (Calcium orthophosphate)
Chemical formulaCa5(PO4)3 · OH or Ca3(PO4)2
Molecular weight502 or 310
AssayContent not less than 90 % calculated on the ignited basis
P2O5 contentBetween 38,5 % and 48,0 % on the anhydrous basis
DescriptionA white, odourless powder which is stable in air
A.Positive tests for calcium and for phosphate
B.SolubilityPractically insoluble in water; insoluble in etanol, soluble in dilute hydrochloric and nitric acid
Loss on ignitionNot more than 8 % after ignition at 800 °C ± 25 °C, to constant weight
FluorideNot more than 50 mg/kg (expressed as fluorine)
ArsenicNot more than 3 mg/kg
CadmiumNot more than 1 mg/kg
LeadNot more than 4 mg/kg
MercuryNot more than 1 mg/kg
SynonymsCalcium disodium EDTACalcium disodium edetate
Chemical nameN,N′-1,2-Ethanediylbis [N-(carboxymethyl)-glycinate] [(4-)-O,O′,ON,ON]calciate(2)-disodiumCalcium disodium ethylenediaminetetra acetateCalcium disodium (ethylenedinitrilo)tetra acetate
Einecs200-529-9
Chemical formulaC10H12O8CaN2Na2·2H2O
Molecular weight410,31
AssayContent not less than 97 % on the anhydrous basis
DescriptionWhite, odourless crystalline granules or white to nearly white powder, slightly hygroscopic
A. Positive tests for sodium and for calcium
B. Chelating activity to metal ions positive
C. pH of a 1 % solution between 6,5 and 7,5
Water content5 to 13 % (Karl Fischer method)
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Ethylene oxide may not be used for sterilising purposes in food additives
DefinitionLinear glycuronoglycan consisting mainly of β-(1-4) linked D-mannuronic and α-(1-4) linked L-guluronic acid units in pyranose ring form. Hydrophilic colloidal carbohydrate extracted by the use of dilute alkali from natural strains of various species of brown seaweeds (Phaeophyceae)
Einecs232-680-1
Chemical formula(C6H8O6)n
Molecular weight10000600000 (typical average)
AssayAlginic acid yields, on the anhydrous basis, not less than 20 % and not more than 23 % of carbon dioxide (CO2), equivalent to not less than 91 % and not more than 104,5 % of alginic acid (C6H8O6)n (calculted on equivalent weight basis of 200)
DescriptionAlginic acid occurs in filamentous, grainy, granular and powdered forms. It is a white to yellowish brown and nearly odourless
A. SolubilityInsoluble in water and organic solvents, slowly soluble in solutions of sodium carbonate, sodium hydroxide and trisodium phosphate
B. Calcium chloride precipitation testTo a 0,5 % solution of the sample in 1 M sodium hydroxide solution, add one fifth of its volume of a 2,5 % solution of calcium chloride. A voluminous, gelatinous precipitate is formed. This test distinguishes alginic acid from acacia gum, sodium carboxymethyl cellulose, carboxymethyl starch, carrageenan, gelatin, gum ghatti, karaya gum, locust bean gum, methyl cellulose and tragacanth gum
C. Ammonium sulphate precipitation testTo a 0,5 % solution of the sample in 1 M sodium hydroxide solution, add one half of its volume of a saturated solution of ammonium sulphate. No precipitate is formed. This test distinguishes alginic acid from agar, sodium carboxymethyl cellulose, carrageenan, de-esterified pectin, gelatin, locust bean gum, methyl cellulose and starch
D. Colour reactionDissolve as completely as possible 0,01 g of the sample by shaking with 0,15 ml of 0,1 N sodium hydroxide and add 1 ml of acid ferric sulphate solution. Within 5 minutes, a cherry-red colour develops that finally becomes deep purple
pH of a 3 % suspensionBetween 2,0 and 3,5
Loss on dryingNot more than 15 % (105 °C, 4 hours)
Sulphated ashNot more than 8 % on the anhydrous basis
Sodium hydroxide (1 M solution)Not more than 2 % on the anhydrous basis insoluble matter
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 20 mg/kg
Total plate countNot more than 5000 colonies per gram
Yeast and mouldsNot more than 500 colonies per gram
E. coliNegative in 5 g
Salmonella spp.Negative in 10 g
Chemical nameSodium salt of alginic acid
Chemical formula(C6H7NaO6)n
Molecular weight10000-600000 (typical average)
AssayYields, on the anhydrous basis, not less than 18 % and not more than 21 % of carbon dioxide corresponding to not less than 90,8 % and not more than 106,0 % of sodium alginate (calculated on equivalent weight basis of 222)
DescriptionNearly odourless, white to yellowish fibrous or granular powder
A. Positive test for sodium and alginic acid
Loss on dryingNot more than 15 % (105 °C, 4 hours)
Water-insoluble matterNot more than 2 % on the anhydrous basis
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 20 mg/kg
Total plate countNot more than 5000 colonies per gram
Yeast and mouldsNot more than 500 colonies per gram
E. coliNegative in 5 g
Salmonella spp.Negative in 10 g
Chemical namePotassium salt of alginic acid
Chemical formula(C6H7KO6)n
Molecular weight10000-600000 (typical average)
AssayYields, on the anhydrous basis, not less than 16,5 % and not more than 19,5 % of carbon dioxide corresponding to not less than 89,2 % and not more than 105,5 % of potassium alginate (calculated on an equivalent weight basis of 238)
DescriptionNearly odourless, white to yellowish fibrous or granular powder
A. Positive test for potassium and for alginic acid
Loss on dryingNot more than 15 % (105 °C, 4 hours)
Water-insoluble matterNot more than 2 % on the anhydrous basis
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 20 mg/kg
Total plate countNot more than 5000 colonies per gram
Yeast and mouldsNot more than 500 colonies per gram
E. coliNegative in 5 g
Salmonella spp.Negative in 10 g
Chemical nameAmmonium salt of alginic acid
Chemical formula(C6H11NO6)n
Molecular weight10000-600000 (typical average)
AssayYields, on the anhydrous basis, not less than 18 % and not more than 21 % of carbon dioxide corresponding to not less than 88,7 % and not more than 103,6 % ammonium alginate (calculated on an equivalent weight basis of 217)
DescriptionWhite to yellowish fibrous or granular powder
A. Positive test for ammonium and alginic acid
Loss on dryingNot more than 15 % (105 °C, 4 hours)
Sulphated ashNot more than 7 % on the dried basis
Water-insoluble matterNot more than 2 % on the anhydrous basis
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metalsNot more than 20 mg/kg
Total plate countNot more than 5000 colonies per gram
Yeast and mouldsNot more than 500 colonies per gram
E. coliNegative in 5 g
Salmonella spp.Negative in 10 g
SynonymsCalcium salt of alginate
Chemical nameCalcium salt of alginic acid
Chemical formula(C6H7Ca1/2O6)n
Molecular weight10000-600000 (typical average)
AssayYields, on the anhydrous basis, not less than 18 % and not more than 21 % carbon dioxide corresponding to not less than 89,6 % and not more than 104,5 % of calcium alginate (calculated on an equivalent weight basis of 219)
DescriptionNearly odourless, white to yellowish fibrous or granular powder
A. Positive test for calcium and alginic acid
Loss on dryingNot more than 15,0 % (105 °C, 4 hours)
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 20 mg/kg
Total plate countNot more than 5000 colonies per gram
Yeast and mouldsNot more than 500 colonies per gram
E. coliNegative in 5 g
Salmonella spp.Negative in 10 g
SynonymsHydroxypropyl alginate1,2-propanediol ester of alginic acidPropylene glycol alginate
Chemical namePropane-1,2-diol ester of alginic acid; varies in composition according to its degree of esterification and the percentage of free and neutralised carboxyl groups in the molecule
Chemical formula(C9H14O7)n(esterified)
Molecular weight10000600000 (typical average)
AssayYields, on the anhydrous basis, not less than 16 % and not more than 20 % of CO2 of carbon dioxide
DescriptionNearly odourless, white to yellowish brown fibrous or granular powder
A. Positive test for 1,2-propanediol and alginic acid after hydrolysis
Loss on dryingNot more than 20 % (105 °C, 4 hours)
Total propane-1,2-diol contentNot less than 15 % and not more than 45 %
Free propane-1,2-diol contentNot more than 15 %
Water-insoluble matterNot more than 2 % on the anhydrous basis
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 20 mg/kg
Total plate countNot more than 5000 colonies per gram
Yeast and mouldsNot more than 500 colonies per gram
E. coliNegative in 5 g
Salmonella spp.Negative in 10 g
SynonymsGeloseJapan agarBengal, Ceylon, Chinese or Japanese isinglassLayor Carang
Chemical nameAgar is a hydrophilic colloidal polysaccharide consisting mainly of D-galactose units. On about every tenth D-galactopyranose unit one of the hydroxyl groups is esterified with sulphuric acid which is neutralised by calcium, magnesium, potassium or sodium. It is extracted from certain natural strains of marine algae of the families Gelidiaceae und Sphaerococcaceae and related red algae of the class Rhodophyceae
Einecs232-658-1
AssayThe threshold gel concentration should not be higher than 0,25 %
DescriptionAgar is odourless or has a slight characteristic odour. Unground agar usually occurs in bundles consisting of thin, membranous, agglutinated strips, or in cut, flaked or granulated forms. It may be light yellowish-orange, yellowish-grey to pale yellow, or colourless. It is tough when damp, brittle when dry. Powdered agar is white to yellowish-white or pale yellow. When examined in water under a microscope, the agar appears granular and somewhat filamentous. A few fragments of the spicules of sponges and a few frustules of diatoms may be present. In chloral hydrate solution, the powdered agar appears more transparent than in water, more or less granular, striated, angular and occasionally contains frustules of diatoms. Gel strength may be standardised by the addition of dextrose and maltodextrines or sucrose
A. SolubilityInsoluble in cold water; soluble in boiling water
Loss on dryingNot more than 22 % (105 °C, 5 hours)
AshNot more than 6,5 % on the anhydrous basis determined at 550 °C
Acid-insoluble ash (insoluble in approximately 3N Hydrochloric acid)Not more than 0,5 % determined at 550 °C on the anhydrous basis
Insoluble matter (in hot water)Not more than 1,0 %
StarchNot detectable by the following method: to a 1 in 10 solution of the sample add a few drops of iodine solution. No blue colour is produced
Gelatin and other proteinsDissolve about 1 g of agar in 100 ml of boiling water and allow to cool of about 50 °C. To 5 ml of the solution add 5 ml of trinitrophenol solution (1 g of anhydrous trinitrophenol/100 ml of hot water). No turbidity appears within 10 minutes
Water absorptionPlace 5 g to agar in a 100 ml graduated cylinder, fill to the mark with water, mix and allow to stand at about 25 °C for 24 hours. Pour the contents of the cylinder through moistened glass wool, allowing the water to drain into a second 100 ml graduated cylinder. Not more than 75 ml of water is obtained
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 20 mg/kg
SynonymsProducts of commerce are sold under different names such as:Irish moss geloseEucheuman (from Eucheuma spp.)Iridophycan (from Irdidaea spp.)Hypnean (from Hypnea spp.)Furcellaran or Danish agar (from Furcellaria fastigiata)Carrageenan (from Chondrus and Gigartina spp.)
DefinitionCarrageenan is obtained by aqueous extraction of natural strains of seaweeds of Gigartinaceae, Solieriaceae, Hypneaceae and Furcellariaceae, families of the class Rhodophyceae (red seaweeds). No organic precipitant shall be used other than methanol, ethanol and propane-2-ol. Carrageenan consists chiefly of the potassium, sodium, magnesium and calcium salts of polysaccharide sulphate esters which, on hydrolysis, yield galactose and 3,6-anhydrogalactose. Carrageenan shall not be hydrolysed or otherwise chemically degraded
Einecs232-524-2
DescriptionYellowish to colourless, coarse to fine powder which is practically odourless
A. Positive tests for galactose, for anhydrogalactose and for sulphate
Methanol, ethanol propane-2-ol contentNot more than 0,1 % singly or in combination
Viscosity of a 1,5 % solution at 75 °CNot less than 5 mPa.s
Loss on dryingNot more than 12 % (105 °C, 4 hours)
SulphateNot less than 15 % and not more than 40 % on the anhydrous basis (as SO4)
AshNot less than 15 % and not more than 40 % determined on the anhydrous basis at 550 °C
Acid-insoluble ashNot more than 1 % on the anhydrous basis (insoluble in 10 % hydrochloric acid)
Acid-insoluble matterNot more than 2 % on the anhydrous basis (insoluble in 1 % v/v sulphuric acid)
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 20 mg/kg
Total plate countNot more than 5000 colonies per gram
Yeast and mouldsNot more than 300 colonies per gram
E. coliNegative in 5 g
Salmonella spp.Negative in 10 g
SynonymsPES (acronym for processed eucheuma seaweed)
DefinitionProcessed eucheuma seaweed is obtained by aqueous alkaline (KOH) treatment of the natural strains of seaweeds Eucheuma cottonii und Eucheuma spinosum, of the class Rhodophyceae (red seaweeds) to remove impurities and by fresh water washing and drying to obtain the product. Further purification may be achieved by washing with methanol, ethanol or propane-2-ol and drying. The product consists chiefly of the potassium salts of polysaccharide sulphate esters which, on hydrolysis, yield galactose and 3,6-anhydrogalactose. Sodium, calcium and magnesium salts of the polysaccharide sulphate esters are present in lesser amounts. Up to 15 % algal cellulose is also present in the product. The carrageenan in processed eucheuma seaweed shall not be hydrolysed or otherwise chemically degraded
DescriptionTan to yellowish, coarse to fine powder which is practically odourless
A. Positive tests for galactose, for anhydrogalactose and for sulphate
B. SolubilityForms cloudy viscous suspensions in water. Insoluble in ethanol
Methanol, ethanol, propane-2-ol contentNot more than 0,1 % singly or in combination
Viscosity of a 1,5 % solution at 75 °CNot less than 5 mPa.s
Loss on dryingNot more than 12 % (105 °C, 4 hours)
SulphateNot less than 15 % and not more than 40 % on the dried basis (as SO4)
AshNot less than 1 % and not more than 40 % determined on the dried basis at 550 °C
Acid-insoluble ashNot more than 1 % on the dried basis (insoluble in 10 % hydrochloric acid)
Acid-insoluble matterNot less than 8 % and not more than 15 % on the dried basis (insoluble in 1 % v/v sulphuric acid)
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 20 mg/kg
Total plate countNot more than 5000 colonies per gram
Yeast and mouldNot more than 300 colonies per gram
E. coliNegative in 5 g
Salmonella spp.Negative in 10 g
SynonymsCarob bean gumAlgaroba gum
DefinitionLocust bean gum is the ground endosperm of the seeds of the natural strains of carob tree, Cerationia siliqua (L.) Taub. (family Leguminosae). Consists mainly of a high molecular weight hydrocolloidal polysaccharide, composed of galactopyranose and mannopyranose units combined through glycosidic linkages, which may be described chemically as galactomannan
Molecular weight500003000000
Einecs232-541-5
AssayGalactomannan content not less than 75 %
DescriptionWhite to yellowish-white, nearly odourless powder
A. Positive tests for galactose mannose
B. Microscopic examinationPlace some ground sample in an aqueous solution containing 0,5 % iodine and 1 % potassium iodide on a glass slide and examine under microscope. Locust bean gum contains long stretched tubiform cells, separated or slightly interspaced. Their brown contents are much less regularly formed in guar gum. Guar gum shows close groups of round to pear shaped cells. Their contents are yellow to brown
C. SolubilitySoluble in hot water, insoluble in ethanol
Loss on dryingNot more than 15 % (105 °C, 5 hours)
AshNot more than 1,2 % determined at 800 °C
Protein (N × 6,25)Not more than 7 %
Acid-insoluble matterNot more than 4 %
StarchNot detectable by the following method: to a 1 in 10 solution of the sample add a few drops of iodine solution. No blue colour is produced
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 20 mg/kg
Ethanol and propane-2-olNot more than 1 %, single or in combination
SynonymsGum cyamopsisGuar flour
DefinitionGuar gum is the ground endosperm of the seeds of natural strains of the guar plant, Cyamopsis tetragonolobus (L.) Taub. (family Leguminosae). Consists mainly of a high molecular weight hydrocolloidal polysaccharide composed of galactopyranose and mannopyranose units combined through glycosidic linkages, which may be described chemically as galactomannan
Einecs232-536-0
Molecular weight500008000000
AssayGalactomannan content not less than 75 %
DescriptionA white to yellowish-white, nearly odourless powder
A. Positive tests for galactose and for mannose
B. SolubilitySoluble in cold water
Loss on dryingNot more than 15 % (105 °C, 5 hours)
AshNot more than 1,5 % determined at 800 °C
Acid-insoluble matterNot more than 7 %
Protein (N × 6,25)Not more than 10 %
StarchNot detectable by the following method: to a 1 in 10 solution of the sample add a few drops of iodine solution. (No blue colour is produced)
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 20 mg/kg
SynonymsTragacanth gumTragant
DefinitionTragacanth is a dried exudation obtained from the stems and branches of natural strains of Astragalus gummifer Labillardiere and other Asiatic species of Astragalus (family Leguminosae). It consists mainly of high molecular weight polysaccharides (galactoarabans and acidic polysaccharides) which, on hydrolysis, yield galacturonic acid, galactose, arabinose, xylose and fucose. Small amounts of rhamnose and of glucose (derived from traces of starch and/or cellulose) may also be present
Molecular weightApproximately 8000000
Einecs232-252-5
DescriptionUnground Tragacanth gum occurs as flattened, lamellated, straight or curved fragments or as spirally twisted pieces 0,5-2,5 mm thick and up to 3 cm in length. It is white to pale yellow in colour but some pieces may have a red tinge. The pieces are horny in texture, with a short fracture. It is odourless and solutions have an insipid mucilaginous taste. Powdered tragacanth is white to pale yellow or pinkish brown (pale tan) in colour
A. Solubility1 g of the sample in 50 ml of water swells to form a smooth, stiff, opalescent mucilage; insoluble in ethanol and does not swell in 60 % (w/v) aqueous ethanol
Negative test for Karaya gumBoil 1 g with 20 ml of water until a mucilage is formed. Add 5 ml of hydrochloric acid and again boil the mixture for five minutes. No permanent pink or red colour develops
Loss on dryingNot more than 16 % (105 °C, 5 hours)
Total ashNot more than 4 %
Acid insoluble ashNot more than 0,5 %
Acid insoluble matterNot more than 2 %
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 20 mg/kg
Salmonella spp.Negative in 10 g
E. coliNegative in 5 g
SynonymsGum arabic
DefinitionAcacia gum is a dried exudation obtained from the stems and branches of natural strains of Acacia senegal (L) Willdenow or closely related species of Acacia (family Leguminosae). It consists mainly of high molecular weight polysaccharides and their calcium, magnesium and potassium salts, which on hydrolysis yield arabinose, galactose, rhamnose and glucuronic acid
Molecular weightApproximately 350000
Einecs232-519-5
DescriptionUnground acacia gum occurs as white or yellowish-white spheroidal tears of varying sizes or as angular fragments and is sometimes mixed with darker fragments. It is also available in the form of white to yellowish-white flakes, granules, powder or spray-dried material.
A. Solubility1 g dissolves in 2 ml of cold water forming a solution which flows readily and is acid to litmus, insoluble in ethanol
Loss on dryingNot more than 17 % (105 °C, 5 hours) for granular and not more than 10 % (105 °C, 4 hours) for spray-dried material
Total ashNot more than 4 %
Acid insoluble ashNot more than 0,5 %
Acid insoluble matterNot more than 1 %
Starch or dextrinBoil a 1 in 50 solution of the gum and cool. To 5 ml add 1 drop of iodine solution. No bluish or reddish colours are produced
TanninTo 10 ml of a 1 in 50 solution add about 0,1 ml of ferric chloride solution (9 g FeCl3.6H2O made up to 100 ml with water). No blackish colouration or blackish precipitate is formed
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 20 mg/kg
Hydrolysis productsMannose, xylose and galacturonic acid are absent (determined by chromatography)
Salmonella spp.Negative in 10 g
E. coliNegative in 5 g
DefinitionXanthan gum is a high molecular weight polysaccharide gum produced by a pure-culture fermentation of a carbohydrate with natural strains of Xanthomonas campestris, purified by recovery with ethanol or propane-2-ol, dried and milled. It contains D-glucose and D-mannose as the dominant hexose units, along with D-glucuronic acid and pyruvic acid, and is prepared as the sodium, potassium or calcium salt. Its solutions are neutral
Molecular weightApproximately 1000000
Einecs234-394-2
AssayYields, on dried basis, not less than 4,2 % and not more than 5 % of CO2 corresponding to between 91 % and 108 % of xanthan gum
DescriptionCream-coloured powder
A. SolubilitySoluble in water. Insoluble in ethanol
Loss on dryingNot more than 15 % (105 °C, 2½ hours)
Total ashNot more than 16 % on the anhydrous basis determined at 650 °C after drying at 105 °C for four hours
Pyruvic acidNot less than 1,5 %
NitrogenNot more than 1,5 %
Propane-2-olNot more than 500 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 20 mg/kg
Total plate countNot more than 10000 colonies per gram
Yeast and mouldNot more than 300 colonies per gram
E. coliNegative in 5 g
Salmonella spp.Negative in 10 g
Xanthomonas campestrisViable cells absent
SynonymsKatiloKadayaGum sterculiaSterculiaKaraya, gum karayaKulloKuterra
DefinitionKaraya gum is a dried exudation from the stems and branches of natural strains of: Sterculia urens Roxburgh and other species of Sterculia (family Sterculiaceae) or from Cochlospermum gossypium A.P. De Candolle or other species of Cochlospermum (family Bixaceae). It consists mainly of high molecular weight acetylated polysaccharides, which on hydrolysis yield galactose, rhamnose, and galacturonic acid, together with minor amounts of glucuronic acid
Einecs232-539-4
DescriptionKaraya gum occurs in tears of variable size and in broken irregular pieces having a characteristic semi-crystalline appearance. It is pale yellow to pinkish brown in colour, translucent and horny. Powdered karaya gum is a pale grey to pinkish brown. The gum has a distinctive odour of acetic acid
A. SolubilityInsoluble in ethanol
B. Swelling in ethanol solutionKaraya gum swells in 60 % ethanol distinguishing it from other gums
Loss on dryingNot more than 20 % (105 °C, 5 hours)
Total ashNot more than 8 %
Acid insoluble ashNot more than 1 %
Acid insoluble matterNot more than 3 %
Volatile acidNot less than 10 % (as acetic acid)
StarchNot detectable
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 20 mg/kg
Salmonella spp.Negative in 10 g
E. coliNegative in 5 g
DefinitionTara gum is obtained by grinding the endosperm of the seeds of natural strains of Caesalpinia spinosa (family Leguminosae). It consists chiefly of polysaccharides of high molecular weight composed mainly of galactomannans. The principal component consists of a linear chain of (1-4)-β-D-mannopyranose units with α-D-galactopyranose units attached by (1-6) linkages. The ratio of mannose to galactose in tara gum is 3:1. (In locust bean gum this ratio is 4:1 and in guar gum 2:1)
Einecs254-409-6
DescriptionA white to white-yellow odourless powder
A. SolubilitySoluble in waterInsoluble in ethanol
B. Gel formationTo an aqueous solution of the sample add small amounts of sodium borate. A gel is formed
Loss on dryingNot more than 15 %
AshNot more than 1,5 %
Acid insoluble matterNot more than 2 %
ProteinNot more than 3,5 % (factor N x 5,7)
StarchNot detectable
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 20 mg/kg
DefinitionGellan gum is a high molecular weight polysaccharide gum produced by a pure culture fermentation of a carbohydrate by natural strains of Pseudomonas elodea, purified by recovery with isopropyl alcohol, dried, and milled. The high molecular weight polysaccharide is principally composed of a tetrasaccharide repeating unit of one rhamnose, one glucuronic acid, and two glucoses, and substituted with acyl (glyceryl and acetyl) groups as the O-glycosidically linked esters. The glucuronic acid is neutralised to a mixed potassium, sodium, calcium, and magnesium salt
Einecs275-117-5
Molecular weightApproximately 500000
AssayYields, on the dried basis, not less than 3,3 % and not more than 6,8 % of CO2
DescriptionAn off-white powder
A. SolubilitySoluble in water, forming a viscous solution.Insoluble in ethanol
Loss on dryingNot more than 15 % after drying (105 °C, 2½ hours)
NitrogenNot more than 3 %
Propane-2-olNot more than 750 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 2 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 20 mg/kg
Total plate countNot more than 10000 colonies per gram
Yeast and mouldNot more than 400 colonies per gram
E. coliNegative in 5 g
Salmonella spp.Negative in 10 g
SynonymsGlycerinGlycerine
Chemical names1,2,3-propanetriolGlycerolTrihydroxypropane
Einecs200-289-5
Chemical formulaC3H8O3
Molecular weight92,10
AssayContent not less than 98 % of glycerol on the anhydrous basis
DescriptionClear, colourless hygroscopic syrupy liquid with not more than a slight characteristic odour, which is neither harsh nor disagreeable
A. Acrolein formation on heatingHeat a few drops of the sample in a test tube with about 0,5 g of potassium bisulphate. The characteristic pungent vapours of acrolein are evolved
B. Specific gravity (25/25 °C)Not less than 1,257
C. Refractive index [n]D20Between 1,471 and 1,474
WaterNot more than 5 % (Karl Fischer method)
Sulphated ashNot more than 0,01 % determined at 800 ± 25 °C
ButanetriolsNot more than 0,2 %
Acrolein, glucose and ammonium compoundsHeat a mixture of 5 ml of glycerol and 5 ml of potassium hydroxide solution (1 in 10) at 60 °C for five minutes. It neither becomes yellow nor emits an odour of ammonia
Fatty acids and estersNot more than 0,1 % calculated as butyric acid
Chlorinated compoundsNot more than 30 mg/kg (as chlorine)
ArsenicNot more than 3 mg/kg
LeadNot more than 2 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 5 mg/kg
SynonymsPolyoxyl (40) stearate
polyoxyethylene (40) monostearate
DefinitionA mixture of the mono- and diesters of edible commercial stearic acid and mixed polyoxyethylene diols (having an average polymer length of about 40 oxyethylene units) together with free polyol
AssayContent not less than 97,5 % on the anhydrous basis
DescriptionCream-coloured flakes or waxy solid at 25 °C with a faint odour
A.SolubilitySoluble in water, ethanol, methanol and ethyl acetate. Insoluble in mineral oil
B.Congealing range39 °C — 44 °C
C.Infrared absorption spectrumCharacteristic of a partial fatty acid ester of a polyoxyethylated polyol
WaterNot more than 3 % (Karl Fischer method)
Acid valueNot more than 1
Saponification valueNot less than 25 and not more than 35
Hydroxyl valueNot less than 27 and not more than 40
1,4-dioxaneNot more than 5 mg/kg
Ethylene oxideNot more than 0,2 mg/kg
Ethylene glycols (mono- and di-)Not more than 0,25 %
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
SynonymsPolysorbate 20Polyoxyethylene (20) sorbitan monolaurate
DefinitionA mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial lauric acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
AssayContent not less than 70 % of oxyethylene groups, equivalent to not less than 97,3 % of polyoxyethylene (20) sorbitan monolaurate on the anhydrous basis
DescriptionA lemon to amber-coloured oily liquid at 25 °C with a faint characteristic odour
A. SolubilitySoluble in water, ethanol, methanol, ethyl acetate and dioxane.Insoluble in mineral oil and petroleum ether
B. Infrared absorption spectrumCharacteristic of a partial fatty acid ester of a polyoxyethylated polyol
WaterNot more than 3 % (Karl Fischer method)
Acid valueNot more than 2
Saponification valueNot less than 40 and not more than 50
Hydroxyl valueNot less than 96 and not more than 108
1,4-DioxaneNot more than 5 mg/kg
Free ethylene oxideNot more than 1 mg/kg
Ethylene glycols (mono- and di-)Not more than 0,25 %
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
SynonymsPolysorbate 80
Polyoxyethylene (20) sorbitan monooleate
DefinitionA mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial oleic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
AssayContent not less than 65 % of oxyethylene groups, equivalent to not less than 96,5 % of polyoxyethylene (20) sorbitan monooleate on the anhydrous basis
DescriptionA lemon to amber-coloured oily liquid at 25 °C with a faint characteristic odour
A.SolubilitySoluble in water, ethanol, methanol, ethyl acetate and toluene. Insoluble in mineral oil and petroleum ether
B.Infrared absorption spectrumCharacteristic of a partial fatty acid ester of a polyoxyethylated polyol
WaterNot more than 3 % (Karl Fischer method)
Acid valueNot more than 2
Saponification valueNot less than 45 and not more than 55
Hydroxyl valueNot less than 65 and not more than 80
1,4-dioxaneNot more than 5 mg/kg
Ethylene oxideNot more than 0,2 mg/kg
Ethylene glycols (mono- and di-)Not more than 0,25 %
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
SynonymsPolysorbate 40
Polyoxyethylene (20) sorbitan monopalmitate
DefinitionA mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial palmitic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
AssayContent not less than 66 % of oxyethylene groups, equivalent to not less than 97 % of polyoxyethylene (20) sorbitan monopalmitate on the anhydrous basis
DescriptionA lemon to orange-coloured oily liquid or semi-gel at 25 °C with a faint characteristic odour
A.SolubilitySoluble in water, ethanol, methanol, ethyl acetate and acetone. Insoluble in mineral oil
B.Infrared absorption spectrumCharacteristic of a partial fatty acid ester of a polyoxyethylated polyol
WaterNot more than 3 % (Karl Fischer method)
Acid valueNot more than 2
Saponification valueNot less than 41 and not more than 52
Hydroxyl valueNot less than 90 and not more than 107
1,4-dioxaneNot more than 5 mg/kg
Ethylene oxideNot more than 0,2 mg/kg
Ethylene glycols (mono- and di-)Not more than 0,25 %
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
SynonymsPolysorbate 60Polyoxyethylene (20) sorbitan monostearate
DefinitionA mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial stearic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
AssayContent not less than 65 % of oxyethylene groups, equivalent to not less than 97 % of polyoxyethylene (20) sorbitan monostearate on the anhydrous basis
DescriptionA lemon to orange-coloured oily liquid or semi-gel at 25 °C with a faint characteristic odour
A. SolubilitySoluble in water, ethyl acetate and toluene. Insoluble in mineral oil and vegetable oils
B. Infrared absorption spectrumCharacteristic of a partial fatty acid ester of a polyoxyethylated polyol
WaterNot more than 3 % (Karl Fischer method)
Acid valueNot more than 2
Saponification valueNot less than 45 and not more than 55
Hydroxyl valueNot less than 81 and not more than 96
1,4-DioxaneNot more than 5 mg/kg
Free ethylene oxideNot more than 1 mg/kg
Ethylene glycols (mono- and di-)Not more than 0,25 %
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
SynonymsPolysorbate 65
Polyoxyethylene (20) sorbitan tristearate
DefinitionA mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial stearic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
AssayContent not less than 46 % of oxyethylene groups, equivalent to not less than 96 % of polyoxyethylene (20) sorbitan tristearate on the anhydrous basis
DescriptionA tan-coloured, waxy solid at 25 °C with a faint characteristic odour
A.SolubilityDispersible in water. Soluble in mineral oil, vegetal oils, petroleum ether, acetone, ether, dioxane, ethanol and methanol
B.Congealing range29 — 33 °C
C.Infrared absorption spectrumCharacteristic of a partial fatty acid ester of a polyoxyethylated polyol
WaterNot more than 3 % (Karl Fischer method)
Acid valueNot more than 2
Saponification valueNot less than 88 and not more than 98
Hydroxyl valueNot less than 40 and not more than 60
1,4-dioxaneNot more than 5 mg/kg
Ethylene oxideNot more than 0,2 mg/kg
Ethylene glycols (mono- and di-)Not more than 0,25 %
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
DefinitionPectin consists mainly of the partial methyl esters of polygalacturonic acid and their ammonium, sodium, potassium and calcium salts. It is obtained by extraction in an aqueous medium of natural strains of appropriate edible plant material, usually citrus fruits or apples. No organic precipitant shall be used other than methanol, ethanol and propane-2-ol
Einecs232-553-0
AssayContent not less than 65 % of galacturonic acid on the ash-free and anhydrous basis after washing with acid and alcohol
DescriptionWhite, light yellow, light grey or light brown powder
A. SolubilitySoluble in water forming a colloidal, opalescent solution. Insoluble in ethanol
Loss on dryingNot more than 12 % (105 °C, 2 hours)
Acid insoluble ashNot more than 1 % (insoluble in approximately 3N hydrochloric acid)
Sulphur dioxideNot more than 50 mg/kg on the anhydrous basis
Nitrogen contentNot more than 1,0 % after washing with acid and ethanol
Free methanol, ethanol and propane-2-olNot more than 1 %, singly or in combination, on the anhydrous basis
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 20 mg/kg
DefinitionAmidated pectin consists mainly of the partial methyl esters and amides of polygalacturonic acid and their ammonium, sodium, potassium and calcium salts. It is obtained by extraction in an aqueous medium of appropriate natural strains of edible plant material, usually citrus fruits or apples and treatment with ammonia under alkaline conditions. No organic precipitant shall be used other than methanol, ethanol and propane-2-ol
AssayContent not less than 65 % of galacturonic acid on the ash-free and anhydrous basis after washing with acid and alcohol
DescriptionWhite, light yellow, light greyish or light brownish powder
A. SolubilitySoluble in water forming a colloidal, opalescent solution. Insoluble in ethanol
Loss on dryingNot more than 12 % (105 °C, 2 hours)
Acid-insoluble ashNot more than 1 % (insoluble in approximately 3N hydrochloric acid)
Degree of amidationNot more than 25 % of total carboxyl groups
Sulphur dioxide residueNot more than 50 mg/kg on the anhydrous basis
Nitrogen contentNot more than 2,5 % after washing with acid and ethanol
Free methanol, ethanol and propane-2-olNot more than 1 % single or in combination, on a volatile matter-free basis
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 20 mg/kg
SynonymsAmmonium salts of phosphatidic acid, mixed ammonium salts of phoshorylated glycerides
DefinitionA mixture of the ammonium compounds of phosphatidic acids derived from edible fat and oil (usually partially hardened rapeseed oil). One or two or three glyceride moieties may be attached to phosphorus. Moreover, two phosphorus esters may be linked together as phosphatidyl phosphatides
AssayThe phosphorus content is not less than 3 % and not more than 3,4 % by weight; the ammonium content is not less than 1,2 % and not more than 1,5 % (calculated as N)
DescriptionUnctuous semi-solid
A. SolubilitySoluble in fats. Insoluble in water. Partially soluble in ethanol and in acetone
B. Positive tests for glycerol, for fatty acid and for phosphate
Petroleum ether insoluble matterNot more than 2,5 %
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
SynonymsSAIB
DefinitionSucrose acetate isobutyrate is a mixture of the reaction products formed by the esterification of food grade sucrose with acetic acid anhydride and isobutyric anhydride, followed by distillation. The mixture contains all possible combinations of esters in which the molar ratio of acetate to butyrate is about 2:6
Einecs204-771-6
Chemical nameSucrose diacetate hexaisobutyrate
Chemical formulaeC40H62O19
Molecular weight832-856 (approximate), C40H62O19: 846,9
AssayContent not less than 98,8 % and not more than 101,9 % of C40H62O19
DescriptionA pale straw-coloured liquid, clear and free of sediment and having a bland odour
A. SolubilityInsoluble in water. Soluble in most organic solvents
B. Refractive indexn40D: 1,4492 - 1,4504
C. Specific gravityd25D: 1,141 - 1,151
TriacetinNot more than 0,1 %
Acid valueNot more than 0,2
Saponification valueNot less than 524 and not more than 540
ArsenicNot more than 3 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
LeadNot more than 3 mg/kg
Heavy metals (as Pb)Not more than 5 mg/kg
SynonymsEster gum
DefinitionA complex mixture of tri- and diglycerol esters of resin acids from wood rosin. The rosin is obtained by the solvent extraction of aged pine stumps followed by a liquid-liquid solvent refining process. Excluded from these specifications are substances derived from gum rosin, and exudate of living pine trees, and substances derived from tall oil rosin, a by-product of kraft (paper) pulp processing. The final product is composed of approximately 90 % resin acids and 10 % neutrals (non-acidic compounds). The resin acid fraction is a complex mixture of isomeric diterpenoid monocarboxylic acids having the empirical molecular formula of C20H30O2, chiefly abietic acid. The substance is purified by steam stripping or by countercurrent steam distillation
DescriptionHard, yellow to pale amber-coloured solid
A. SolubilityInsoluble in water, soluble in acetone
B. Infrared absorption spectrumCharacteristic of the compound
Specific gravity of solutiond2025 not less than 0,935 when determined in a 50 % solution in d-limonene (97 %, boilding point 175,5-176 °C,d204: 0,84)
Ring and ball softening rangeBetween 82 °C and 90 °C
Acid valueNot less than 3 and not more than 9
Hydroxyl valueNot less than 15 and not more than 45
ArsenicNot more than 3 mg/kg
LeadNot more than 2 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Test for absence of tall oil rosin (sulphur test)When sulphur-containing organic compounds are heated in the presence of sodium formate, the sulphur is converted to hydrogen sulphide which can readily be detected by the use of lead acetate paper. A positive test indicates the use of tall oil rosin instead of wood rosin
SynonymsDisodium dihydrogen diphosphateDisodium dihydrogen pyrophosphateSodium acid pyrophosphateDisodium pyrophosphate
Chemical nameDisodium dihydrogen diphosphate
Einecs231-835-0
Chemical formulaNa2H2P2O7
Molecular weight221,94
AssayContent not less than 95 % of disodium diphosphate.
P2O5 ContentNot less than 63,0 % and not more than 64,5 %
DescriptionWhite powder or grains
A.Positive tests for sodium and for phosphate
B.SolubilitySoluble in water
C.pH of a 1 % solutionBetween 3,7 and 5,0
Loss on dryingNot more than 0,5 % (105 °C, four hours)
Water-insoluble matterNot more than 1 %
FluorideNot more than 10 mg/kg (expressed as fluorine)
ArsenicNot more than 3 mg/kg
CadmiumNot more than 1 mg/kg
LeadNot more than 4 mg/kg
MercuryNot more than 1 mg/kg
SynonymsAcid trisodium pyrophosphateTrisodium monohydrogen diphosphate
Einecs238-735-6
Chemical formulaMonohydrate: Na3HP2O7 · H2OAnhydrous: Na3HP2O7
Molecular weightMonohydrate: 261,95Anhydrous: 243,93
AssayContent not less than 95 % on the anhydrous basis
P2O5 contentNot less than 57 % and not more than 59 %
DescriptionWhite powder or grains, occurs anhydrous or as a monohydrate
A.Positive tests for sodium and for phosphate
B.Soluble in water
C.pH of a 1 % solutionBetween 6,7 and 7,5
Loss on ignitionNot more than 4,5 % on the anhydrous compoundNot more than 11,5 % on the monohydrous basis
Loss on dryingNot more than 0,5 % (105 °C, four hours)
Water-insoluble matterNot more than 0,2 %
FluorideNot more than 10 mg/kg (expressed as fluorine)
ArsenicNot more than 3 mg/kg
CadmiumNot more than 1 mg/kg
LeadNot more than 4 mg/kg
MercuryNot more than 1 mg/kg
SynonymsTetrasodium pyrophosphateSodium pyrophosphate
Chemical nameTetrasodium diphosphate
Einecs231-767-1
Chemical formulaAnhydrous: Na4P2O7Decahydrate: Na4P2O7 · 10H2O
Molecular weightAnhydrous: 265,94Decahydrate: 446,09
AssayContent not less than 95 % of Na4P2O7 on the ignited basis
P2O5 contentNot less than 52,5 % and not more than 54,0 %
DescriptionColourless or white crystals, or a white crystalline or granular powder. The decahydrate effloresces slightly in dry air
A.Positive tests for sodium and for phosphate
B.SolubilitySoluble in water. Insoluble in ethanol
C.pH of a 1 % solutionBetween 9,8 and 10,8
Loss on ignitionNot more than 0,5 % for the anhydrous salt, not less than 38 % and not more than 42 % for the decahydrate, in both cases determined after drying at 105 °C for four hours, followed by ignition at 550 °C for 30 minutes
Water-insoluble matterNot more than 0,2 %
FluorideNot more than 10 mg/kg (expressed as fluorine)
ArsenicNot more than 3 mg/kg
CadmiumNot more than 1 mg/kg
LeadNot more than 4 mg/kg
MercuryNot more than 1 mg/kg
SynonymsPotassium pyrophosphateTetrapotassium pyrophosphate
Chemical nameTetrapotassium diphosphate
Einecs230-785-7
Chemical formulaK4P2O7
Molecular weight330,34 (anhydrous)
AssayContent not less than 95 % on the ignited basis
P2O5 contentNot less than 42,0 % and not more than 43,7 % on the anhydrous basis
DescriptionColourless crystals or white, very hygroscopic powder
A.Positive tests for potassium and for phosphate
B.SolubilitySoluble in water, insoluble in ethanol
C.pH of a 1 % solutionBetween 10,0 and 10,8
Loss on ignitionNot more than 2 % after drying at 105 °C for four hours and then ignition at 550 °C for 30 minutes
Water-insoluble substancesNot more than 0,2 %
FluorideNot more than 10 mg/kg (expressed as fluorine)
ArsenicNot more than 3 mg/kg
CadmiumNot more than 1 mg/kg
LeadNot more than 4 mg/kg
MercuryNot more than 1 mg/kg
SynonymsCalcium pyrophosphate
Chemical nameDicalcium diphosphateDicalcium pyrophosphate
Einecs232-221-5
Chemical formulaCa2P2O7
Molecular weight254,12
AssayContent not less than 96 %
P2O5 contentNot less than 55 % and not more than 56 %
DescriptionA fine, white, odourless powder
A.Positive tests for calcium and for phosphate
B.SolubilityInsoluble in water. Soluble in dilute hydrochloric and nitric acids
C.pH of a 10 % suspension in waterBetween 5,5 and 7,0
Loss on ignitionNot more than 1,5 % at 800 °C ± 25 °C for 30 minutes
FluorideNot more than 50 mg/kg (expressed as fluorine)
ArsenicNot more than 3 mg/kg
CadmiumNot more than 1 mg/kg
LeadNot more than 4 mg/kg
MercuryNot more than 1 mg/kg
SynonymsAcid calcium pyrophosphateMonocalcium dihydrogen pyrophosphate
Chemical nameCalcium dihydrogen diphosphate
Einecs238-933-2
Chemical formulaCaH2P2O7
Molecular weight215,97
AssayContent not less than 90 % on the anhydrous basis
P2O5 contentNot less than 61 % and not more than 64 %
DescriptionWhite crystals or powder
A.Positive tests for calcium and for phosphate
Acid-insoluble matterNot more than 0,4 %
FluorideNot more than 30 mg/kg (expressed as fluorine)
ArsenicNot more than 3 mg/kg
CadmiumNot more than 1 mg/kg
LeadNot more than 4 mg/kg
MercuryNot more than 1 mg/kg
SynonymsPentasodium tripolyphosphateSodium tripolyphosphate
Chemical namePentasodium triphosphate
Einecs231-838-7
Chemical formulaNa5O10P3 · nH2O (n = 0 or 6)
Molecular weight367,86
AssayContent not less than 85,0 % (anhydrous) or 65,0 % (hexahydrate)
P2O5 contentNot less than 56 % and not more than 59 % (anhydrous) or not less than 43 % and not more than 45 % (hexahydrate)
DescriptionWhite, slightly hygroscopic granules or powder
A.SolubilityFreely soluble in water. Insoluble in ethanol
B.Positive tests for sodium and for phosphate
C.pH of a 1 % solutionBetween 9,1 and 10,2
Loss on dryingAnhydrous: Not more than 0,7 % (105 °C, one hour)Hexahydrate: Not more than 23,5 % (60 °C, one hour, followed by drying at 105 °C, four hours)
Water-insoluble substancesNot more than 0,1 %
Higher polyphosphatesNot more than 1 %
FluorideNot more than 10 mg/kg (expressed as fluorine)
ArsenicNot more than 3 mg/kg
CadmiumNot more than 1 mg/kg
LeadNot more than 4 mg/kg
MercuryNot more than 1 mg/kg
SynonymsPentapotassium tripolyphosphatePotassium triphosphatePotassium tripolyphosphate
Chemical namePentapotassium triphosphatePentapotassium tripolyphosphate
Einecs237-574-9
Chemical formulaK5O10P3
Molecular weight448,42
AssayContent not less than 85 % on the anhydrous basis
P2O5 contentNot less than 46,5 % and not more than 48 %
DescriptionWhite, very hygroscopic powder or granules
A.SolubilityVery soluble in water
B.Positive tests for potassium and for phosphate
C.pH of a 1 % solutionBetween 9,2 and 10,5
Loss on ignitionNot more than 0,4 % (after drying at 105 °C, four hours, followed by ignition at 550 °C, 30 minutes)
Water-insoluble matterNot more than 2 %
FluorideNot more than 10 mg/kg (expressed as fluorine)
ArsenicNot more than 3 mg/kg
CadmiumNot more than 1 mg/kg
LeadNot more than 4 mg/kg
MercuryNot more than 1 mg/kg
SynonymsSodium hexametaphosphateSodium tetrapolyphosphateGraham's saltSodium polyphosphates, glassySodium polymetaphosphateSodium metaphosphate
DefinitionSoluble sodium polyphosphates are obtained by fusion and subsequent chilling of sodium orthophosphates. These compounds are a class consisting of several amorphous, water-soluble polyphosphates composed of linear chains of metaphosphate units, (NaPO3)x where x ≥ 2, terminated by Na2PO4 groups. These substances are usually identified by their Na2O/P2O5 ratio or their P2O5 content. The Na2O/P2O5 ratios vary from about 1,3 for sodium tetrapolyphosphate, where x = approximately 4; to about 1,1 for Graham's salt, commonly called sodium hexametaphosphate, where x = 13 to 18; and to about 1,0 for the higher molecular weight sodium polyphosphates, where x = 20 to 100 or more. The pH of their solutions varies from 3,0 to 9,0
Chemical nameSodium polyphosphate
Einecs272-808-3
Chemical formulaHeterogenous mixtures of sodium salts of linear condensed polyphosphoric acids of general formula H(n + 2)PnO(3n + 1) where "n" is not less than 2
Molecular weight(102)n
Assay P2O5 contentNot less than 60 % and not more than 71 % on the ignited basis
DescriptionColourless or white, transparent platelets, granules, or powders
A.SolubilityVery soluble in water
B.Positive tests for sodium and for phosphate
C.pH of a 1 % solutionBetween 3,0 and 9,0
Loss on ignitionNot more than 1 %
Water-insoluble matterNot more than 0,1 %
FluorideNot more than 10 mg/kg (expressed as fluorine)
ArsenicNot more than 3 mg/kg
CadmiumNot more than 1 mg/kg
LeadNot more than 4 mg/kg
MercuryNot more than 1 mg/kg
SynonymsInsoluble sodium metaphosphateMaddrell's saltInsoluble sodium polyphosphate, IMP
DefinitionInsoluble sodium metaphosphate is a high molecular weight sodium polyphosphate composed of two long metaphosphate chains (NaPO3)x that spiral in opposite directions about a common axis. The Na2O/P2O5 ratio is about 1,0. The pH of 1 in 3 suspension in water is about 6,5
Chemical nameSodium polyphosphate
Einecs272-808-3
Chemical formulaHeterogenous mixtures of sodium salts of linear condensed polyphosphoric acids of general formula H(n + 2)PnO(3n + 1) where "n" is not less than 2
Molecular weight(102)n
P2O5 contentNot less than 68,7 % and not more than 70,0 %
DescriptionWhite crystalline powder
A.SolubilityInsoluble in water, soluble in mineral acids and in solutions of potassium and ammonium (but not sodium) chlorides
B.Positive tests for sodium and for phosphate
C.pH of 1 in 3 suspension in waterAbout 6,5
FluorideNot more than 10 mg/kg (expressed as fluorine)
ArsenicNot more than 3 mg/kg
CadmiumNot more than 1 mg/kg
LeadNot more than 4 mg/kg
MercuryNot more than 1 mg/kg
SynonymsPotassium metaphosphatePotassium polymetaphosphateKurrol salt
Chemical namePotassium polyphosphate
Einecs232-212-6
Chemical formula(KPO3)nHeterogenous mixtures of potassium salts of linear condensed polyphosphoric acids of general formula H(n + 2)PnO(3n + 1)where "n" is not less than 2
Molecular weight(118)n
P2O5 contentNot less than 53,5 % and not more than 61,5 % on the ignited basis
DescriptionFine white powder or crystals or colourless glassy platelets
A.Solubility1 g dissolves in 100 ml of a 1 in 25 solution of sodium acetate
B.Positive tests for potassium and for phosphate
C.pH of a 1 % suspensionNot more than 7,8
Loss on ignitionNot more than 2 % (105 °C, four hours followed by ignition at 550 °C, 30 minutes)
Cyclic phosphateNot more than 8 % on P2O5 content
FluorideNot more than 10 mg/kg (expressed as fluorine)
ArsenicNot more than 3 mg/kg
CadmiumNot more than 1 mg/kg
LeadNot more than 4 mg/kg
MercuryNot more than 1 mg/kg
SynonymsCalcium metaphosphateCalcium polymetaphosphate
Chemical nameCalcium polyphosphate
Einecs236-769-6
Chemical formula(CaP2O6)nHeterogenous mixtures of calcium salts of condensed polyphosphoric acids of general formula H(n + 2)PnO(n + 1) where "n" is not less than 2
Molecular weight(198)n
P2O5 contentNot less than 71 % and not more than 73 % on the ignited basis
DescriptionOdourless, colourless crystals or white powder
A.SolubilityUsually sparingly soluble in water. Soluble in acid medium
B.Positive tests for calcium and for phosphate
C.CaO content27 to 29,5 %
Loss on ignitionNot more than 2 % (105 °C, four hours followed by ignition at 550 °C, 30 minutes)
Cyclic phosphateNot more than 8 % on P2O5 content
FluorideNot more than 30 mg/kg (expressed as fluorine)
ArsenicNot more than 3 mg/kg
CadmiumNot more than 1 mg/kg
LeadNot more than 4 mg/kg
MercuryNot more than 1 mg/kg
SynonymsCellulose gel
DefinitionMicrocrystalline cellulose is purified, partally depolymerised cellulose prepared by treating alpha-cellulose, obtained as a pulp from natural strains of fibrous plant material, with mineral acids. The degree of polymerisation is typically less than 400
Chemical nameCellulose
Einecs232-674-9
Chemical formula(C6H10O5)n
Molecular weightAbout 36000
AssayNot less than 97 % calculated as cellulose on the anhydrous basis
DescriptionA fine white or almost white odourless powder
A. SolubilityInsoluble in water, ethanol, ether and dilute mineral acids. Slightly soluble in sodium hydroxide solution
B. Colour reactionTo 1 mg of the sample, add 1 ml of phosphoric acid and heat on a water bath for 30 minutes. Add 4 ml of a 1 in 4 solution of pyrocatechol in phosphoric acid and heat for 30 minutes, A red colour is produced
C. To be identified by IR spectroscopy
D. Suspension testMix 30 g of the sample with 270 ml of water in a high-speed (12000 rpm) power blender for 5 minutes. The resultant mixture will be either a free-following suspension or a heavy, lumpy suspension which flows poorly, if at all, settles only slightly and contains many trapped air bubbles. If a free-flowing suspension is obtained, transfer 100 ml into a 100-ml graduated cylinder and allow to stand for 1 hour. The solids settles and a supernatant liquid appears
Loss on dryingNot more than 7 % (105 °C, 3 hours)
Water-soluble matterNot more than 0,24%
Sulphated ashNot more than 0,5 % determined at 800 ± 25 °C
pH of a 10 % suspension in waterThe pH of the supernatant liquid is between 5,0 and 7,5
StarchNot detectableTo 20 ml of the dispersion obtained in identification, test D, add a few drops of iodine solution and mix. No purplish to blue or blue colour should be produced
Particle sizeNot less than 5 μm (not more than 10 % of particles of less than 5 μm)
Carboxyl groupsNot more than 1 %
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
DefinitionPurified, mechanically disintegrated celluslose prepared by processing alpha-cellulose obtained as a pulp from natural strains of fibrous plant materials
Chemical nameCelluloseLinear polymer of 1:4 linked glucose residues
Einecs232-674-9
Chemical formula(C6H10O5)n
Molecular weight(162)n (n is predominantly 1000 and greater)
AssayContent not less than 92 %
DescriptionA white, odourless powder
A. SolubilityInsoluble in water, ethanol, ether and dilute mineral acids. Slightly soluble in sodium hydroxide solution
B. Suspension testMix 30 g of the sample with 270 ml of water in a high-speed (12000 rpm) power blender for 5 minutes. The resultant mixture will be either a free-flowing suspension or a heavy, lumpy suspension which flows poorly, if at all, settles only slightly and contains many trapped air bubbles. If a free-flowing suspension is obtained, transfer 100 ml into a 100-ml graduated cylinder and allow to stand for 1 hour. The solids settles and a supernatant liquid appears
Loss on dryingNot more than 7 % (105 °C, 3 hours)
Water-soluble matterNot more than 1,0 %
Sulphated ashNot more than 0,3 % determined at 800 ± 25 °C
pH of a 10 % suspension in waterThe pH of the supernatant liquid is between 5,0 and 7,5
StarchNot detectableTo 20 ml of the dispersion obtained in identification, test B, add a few drops of iodine solution and mix. No purplish to blue or blue colour should be produced
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Particle sizeNot less than 5 μm (not more than 10 % of particles of less than 5 μm)
SynonymsCellulose methyl ether
DefinitionMethyl cellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with methyl groups
Chemical nameMethyl ether of cellulose
Chemical formulaThe polymers contain substituted anhydroglucose units with the following general formula:C6H7O2(OR1)(OR2)(OR3) where R1, R2, R3 each may be one of the following:HCH3 orCH2CH3
Molecular weightFrom about 20000 to 380000
AssayContent not less than 25 % and not more than 33 % of methoxyl groups (-OCH3) and not more than 5 % of hydroxyethoxyl groups (-OCH2CH2OH)
DescriptionSlightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder
A. SolubilitySwelling in water, producing a clear to opalescent, viscous, colloidal solution.Insoluble in ehtanol, ether and chloroform.Soluble in glacial acetic acid
Loss on dryingNot more than 10 % (105 °C, 3 hours)
Sulphated ashNot more than 1,5 % determined at 800 ± 25 °C
pH of a 1 % colloidal solutionNot less than 5,0 and not more than 8,0
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 20 mg/kg
SynonymsCellulose hydroxypropyl ether
DefinitionHydroxypropylcellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with hydroxypropyl groups
Chemical nameHydroxypropyl ether of cellulose
Chemical formulaThe polymers contain substituted anhydroglucose units with the following general formula:C6H7O2(OR1)(OR2)(OR3), where R1, R2, R3 each may be one of the following:HCH2CHOHCH3CH2CHO(CH2CHOHCH3)CH3CH2CHO[CH2CHO(CH2CHOHCH3)CH3]CH3
Molecular weightFrom about 30000 to 1000000
AssayContent not less than 80,5 % of hydroxypropoxyl groups (-OCH2CHOHCH3) equivalent to not more than 4,6 hydroxypropyl groups per anhydroglucose unit on the anhydrous basis
DescriptionSlightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder
A. SolubilitySwelling in water, producing a clear to opalescent, viscous, colloidal solution. Soluble in ethanol. Insoluble in ether
B. Gas chromatographyDetermine the substituents by gas chromotography
Loss on dryingNot more than 10 % (105 °C, 3 hours)
Sulphated ashNot more than 0,5 % determined at 800 ± 25 °C
pH of a 1 % colloidal solutionNot less than 5,0 and not more than 8,0
Propylene chlorohydrinsNot more than 0,1 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 20 mg/kg
DefinitionHydroxypropyl methyl cellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with methyl groups and containing a small degree of hydroxypropyl substitution
Chemical name2-Hydroxypropyl ether of methylcellulose
Chemical formulaThe polymers contain substituted anhydroglucose units with the following general formula:C6H7O2(OR1)(OR2)(OR3), where R1, R2 R3 each may be one of the following:HCH3CH2CHOHCH3CH2CHO (CH2CHOHCH3) CH3CH2CHO[CH2CHO (CH2CHOHCH3) CH3]CH3
Molecular weightFrom about 13000 to 200000
AssayContent not less than 19 % and not more than 30 % methoxyl groups (-OCH3) and not less than 3 % and not more than 12 % hydroxypropoxyl groups (-OCH2CHOHCH3), on the anhydrous basis
DescriptionSlightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder
A. SolubilitySwelling in water, producing a clear to opalescent, viscous, colloidal solution. Insoluble in ethanol
B. Gas chromatographyDetermine the substituents by gas chromatography
Loss on dryingNot more than 10 % (105 °C, 3 hours)
Sulphated ashNot more than 1,5 % for products with viscosities of 50 mPa.s or aboveNot more than 3 % for products with viscosities below 50 mPa.s
pH of a 1 % colloidal solutionNot less than 5,0 and not more than 8,0
Propylene chlorohydrinsNot more than 0,1 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 20 mg/kg
SynonymsMethylethylcellulose
DefinitionEthyl methyl cellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with methyl and ethyl groups
Chemical nameEthyl methyl ether of cellulose
Chemical formulaThe polymers contain substituted anhydroglucose units with the following general formula:C6H7O2(OR1)(OR2)(OR3), where R1, R2 R3 each may be one of the following:HCH3CH2CH3
Molecular weightFrom about 30000 to 40000
AssayContent on the anhydrous basis not less than 3,5 % and not more than 6,5 % of methoxyl groups (-OCH3) and not less than 14,5 % and not more than 19 % of ethoxyl groups (-OCH2CH3), and not less than 13,2 % and not more than 19,6 % of total alkoxyl groups, calculated as methoxyl
DescriptionSlightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder
A. SolubilitySwelling in water, producing a clear to opalescent, viscous, colloidal solution. Soluble in ethanol. Insoluble in ether
Loss on dryingNot more than 15 % for the fibrous form, and not more than 10 % for the powdered form (105 °C to constant weight)
Sulphated ashNot more than 0,6 %
pH of a 1 % colloidal solutionNot less than 5,0 and not more than 8,0
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 20 mg/kg
SynonymsCarboxy methyl celluloseCMCNaCMCSodium CMCCellulose gum
DefinitionCarboxy methyl cellulose is the partial sodium salt of a carboxymethyl ether of cellulose, the cellulose being obtained directly from natural strains of fibrous plant material
Chemical nameSodium salt of the carboxymethyl ether of cellulose
Chemical formulaThe polymers contain substituted anhydroglucose units with the following general formula:C6H7O2(OR1)(OR2)(OR3), where R1, R2 R3 each may be one of the following:HCH2COONaCH2COOH
Molecular weightHigher than approximately 17000 (degree of polymerisation approximately 100)
AssayContent on the anhydrous basis not less than 99,5 %
DescriptionSlightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder
A. SolubilityYields a viscous colloidal solution with water. Insoluble in ethanol
B. Foam testA 0,1 % solution of the sample is shaken vigorously. No layer of foam appears. (This test permits the distinction of sodium carboxymethyl cellulose from other cellulose ethers)
C. Precipitate formationTo 5 ml of a 0,5 % solution of the sample, add 5 ml of 5 % solution of copper sulphate or of aluminium sulphate. A precipitate appears. (This test permits the distinction of sodium carboxymethyl cellulose from other cellulose ethers and from gelatine, locust bean gum and tragacanth)
D. Colour reactionAdd 0,5 g powdered carboxy methyl cellulose sodium to 50 ml of water, while stirring to produce an uniform dispersion. Continue the stirring until a clear solution is produced, and use the solution for the following test:To 1 mg of the sample, diluted with an equal volume of water, in a small test tube, add 5 drops of 1-naphthol solution. Incline the test tube, and carefully introduce down the side of the tube 2 ml of sulphuric acid so that it forms a lower layer. A red-purple colour develops at the interface
Degree of substitutionNot less than 0,2 and not more than 1,5 carboxymethyl groups (-CH2COOH) per anhydroglucose unit
Loss on dryingNot more than 12 % (105 °C to constant weight)
pH of a 1 % colloidal solutionNot less than 5,0 and not more than 8,5
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 20 mg/kg
Total glycolateNot more than 0,4 %, calculated as sodium glycolate on the anhydrous basis
SodiumNot more than 12,4 % on the anhydrous basis
DefinitionSodium, potassium and calcium salts of fatty acids occurring in food oils and fats, these salts being obtained either from edible fats and oils or from distilled food fatty acids
AssayContent on the anhydrous basis not less than 95 %
DescriptionWhite or creamy white light powders, flakes or semi-solids
A. SolubilitySodium and potassium salts: soluble in water and ethanol calcium salts: insoluble in water, ethanol and ether
B. Positive tests for cations and for fatty acids
SodiumNot less than 9 % and not more than 14 % expressed as Na2O
PotassiumNot less than 13 % and not more than 21,5 % expressed as K2O
CalciumNot less than 8,5 % and not more than 13 % expressed as CaO
Unsaponifiable matterNot more than 2 %
Free fatty acidsNot more than 3 % estimated as oleic acid
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Free alkaliNot more than 0,1 % expressed as NaOH
Matter insoluble in alcoholNot more than 0,2 % (sodium and potassium salts only)
DefinitionMagnesium salts of fatty acids occurring in foods oils and fats, these salts being obtained either from edible fats and oils or from distilled food fatty acids
AssayContent on the anhydrous basis not less than 95 %
DescriptionWhite or creamy-white light powders, flakes or semi-solids
A. SolubilityInsoluble in water, partially soluble in ethanol and ether
B. Positive tests for magnesium and for fatty acids
MagnesiumNot less than 6,5 % and not more than 11 % expressed as MgO
Free alkaliNot more than 0,1 % expressed as MgO
Unsaponifiable matterNot more than 2 %
Free fatty acidsNot more than 3 % estimated as oleic acid
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
SynonymsGlyceryl monostearateGlyceryl monopalmitateGlyceryl monooleate, etc.Monostearin, monopalmitin, monoolein, etc.GMS (for glyceryl monostearate)
DefinitionMono- and diglycerides of fatty acids consist of mixtures of glycerol mono-, di- and triesters of fatty acids occurring in food oils and fats. They may contain small amounts of free fatty acids and glycerol
AssayContent of mono- and diesters: not less than 70 %
DescriptionThe product varies from a pale yellow to pale brown oily liquid to a white or slightly off-white hard waxy solid. The solids may be in the form of flakes, powders or small beads
A. Infrared spectrumCharacteristic of a partial fatty acid ester of a polyol
B. Positive tests for glycerol and for fatty acids
C. SolubilityInsoluble in water, soluble in ethanol and toluene
Water contentNot more than 2 % (Karl Fischer method)
Acid valueNot more than 6
Free glycerolNot more than 7 %
PolyglycerolsNot more than 4 % diglycerol and not more than 1 % higher polyglycerols both based on total glycerol content
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Total glycerolNot less than 16 % and not more than 33 %
Sulphated ashNot more than 0,5 % determined at 800 ± 25 °C
Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)
SynonymsAcetic acid esters of mono- and diglyceridesAcetoglyceridesAcetylated mono- and diglyceridesAcetic and fatty acid esters of glycerol
DefinitionEsters of glycerol with acetic and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free acetic acid and free glycerides
DescriptionClear, mobile liquids to solids, from white to pale yellow in colour
A. Positive tests for glycerol, for fatty acids and for acetic acid
B. SolubilityInsoluble in water. Soluble in ethanol
Acids other than acetic and fatty acidsNot detectable
Free glycerolNot more than 2 %
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Total acetic acidNot less than 9 % and not more than 32 %
Free fatty acids (and acetic acid)Not more than 3 % estimated as oleic acid
Total glycerolNot less than 14 % and not more than 31 %
Sulphated ashNot more than 0,5 % determined at 800 ± 25 °C
Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)
SynonymsLactic acid esters of mono- and diglyceridesLactoglyceridesMono- and diglycerides of fatty acids esterified with lactic acid
DefinitionEsters of glycerol with lactic acid and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free lactic acid and free glycerides
DescriptionClear, mobile liquids to waxy solids of variable consistency, from white to pale yellow in colour
A. Positive tests for glycerol, for fatty acids and for lactic acid
B. SolubilityInsoluble in cold water but dispersible in hot water
Acids other than lactic and fatty acidsNot detectable
Free glycerolNot more than 2 %
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Total lactic acidNot less than 13 % and not more than 45 %
Free fatty acids (and lactic acid)Not more than 3 % estimated as oleic acid
Total glycerolNot less than 13 % and not more than 30 %
Sulphated ashNot more than 0,5 % determined at 800 ± 25 °C
Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)
SynonymsCitric acid esters of mono- and diglyceridesCitroglyceridesMono- and diglycerides of fatty acids esterified with citric acid
DefinitionEsters of glycerol with citric acid and fatty acids occurring in food oils and fats. They may contain small amounts of free glycerol, free fatty acids, free citric acid and free glycerides. They may be partially or wholly neutralised with sodium hydroxide or with potassium hydroxide
DescriptionYellowish or light brown liquids to waxy solids or semi-solids
A. Positive tests for glycerol, for fatty acids and for citric acid
B. SolubilityInsoluble in cold waterDispersible in hot waterSoluble in oils and fatsInsoluble in cold ethanol
Acids other than citric and fatty acidsNot detectable
Free glycerolNot more than 2 %
Total glycerolNot less than 8 % and not more than 33 %
Total citric acidNot less than 13 % and not more than 50 %
Sulphated ashNot more than 0,5 % determined at 800 ± 25 °C
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Free fatty acidsNot more than 3 % estimated as oleic acid
Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)
SynonymsTartaric acid esters of mono- and diglyceridesMono- and diglycerides of fatty acids esterified with tartaric acid
DefinitionEsters of glycerol with tartaric acid and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric acid and free glycerides
DescriptionSticky viscous yellowish liquids to hard yellow waxes
A. Positive tests for glycerol, for fatty acids and for tartaric acid
Acids other than tartaric and fatty acidsNot detectable
Free glycerolNot more than 2 %
Total glycerolNot less than 12 % and not more than 29 %
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Total tartaric acidNot less than 15 % and not more than 50 %
Free fatty acidsNot more than 3 % estimated as oleic acid
Sulphated ashNot more than 0,5 % determined at 800 ± 25 °C
Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)
SynonymsDiacetyltartaric acid esters of mono- and diglyceridesMono-and diglycerides of fatty acids esterified with mono- and diacetyltartaric acidDiacetyltartaric and fatty acid esters of glycerol
DefinitionMixted esters of glycerol with mono- and diacetyltartaric acids (obtained from tartaric acid) and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric and acetic acids and their combinations, and free glycerides. Contains also tartaric and acetic esters of fatty acids
DescriptionSticky viscous liquids through a fat-like consistency to yellow waxes which hydrolyse in moist air to liberate acetic acid
A. Positive tests for glycerol, for fatty acids, for tartaric acid and for acetic acid
Acids other than acetic, tartaric and fatty acidsNot detectable
Free glycerolNot more than 2 %
Total glycerolNot less than 11 % and not more than 28 %
Sulphated ashNot more than 0,5 % determined at 800 ± 25 °C
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Total tartaric acidNot less than 10 % and not more than 40 %
Total acetic acidNot less than 8 % and not more than 32 %
Free fatty acidsNot more than 3 % estimated as oleic acid
Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)
SynonymsMono- and diglycerides of fatty acids esterified with acetic acid and tartaric acid
DefinitionEsters of glycerol with acetic and tartaric acids and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric and ecetic acids, and free glycerides. May contain mono- and diacetyltartaric esters of mono- and diglycerides of fatty acids
DescriptionSticky liquids to solids, from white to pale-yellow in colour
A. Positive tests for glycerol, for fatty acids, for tartaric acid and for acetic acid
Acids other than acetic, tartaric and fatty acidsNot detectable
Free glycerolNot more than 2 %
Total glycerolNot less than 12 % and not more than 27 %
Sulphated ashNot more than 0,5 % determined at 800 ± 25 °C
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Total acetic acidNot less than 10 % and not more than 20 %
Total tartaric acidNot less than 20 % and not more than 40 %
Free fatty acidsNot more than 3 % estimated as oleic acid
Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)
SynonymsSucroestersSugar esters
DefinitionEssentially the mono-, di- and triesters of sucrose with fatty acids occurring in food fats and oils. They may be prepared from sucrose and the methyl and ethyl esters of food fatty acids or by extraction from sucroglycerides. No organic solvent other than dimethylsulphoxide, dimethylformamide, ethyl acetate, propane-2-ol, 2-methyl-1-propanol, propylene glycol and methyl ethyl ketone may be used for their preparation
AssayContent not less than 80 %
DescriptionStiff gels, soft solids or white to slightly greyish-white powders
A. Positive tests for sugar for fatty acids
B. SolubilitySparingly soluble in waterSoluble in ethanol
Sulphated ashNot more than 2 % determined at 800 ± 25 °C
Free sugarNot more than 5 %
Free fatty acidsNot more than 3 % estimated as oleic acid
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
MethanolNot more than 10 mg/kg
DimethylsulphoxideNot more than 2 mg/kg
DimethylformamideNot more than 1 mg/kg
2-methyl-1-propanolNot more than 10 mg/kg
Ethyl acetatePropane-2-olPropylene glycolNot more than 350 mg/kg, singly or in combination
Methyl ethyl ketoneNot more than 10 mg/kg
Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)
SynonymsSugar glycerides
DefinitionSucroglycerides are produced by reacting sucrose with an edible fat or oil to produce a mixture of essentially mono-, di- and triesters of sucrose and fatty acids together with residual mono-, di- and triglycerides from fat or oil. No organic solvents shall be used in their preparation other than cyclohexane, dimethylformamide, ethyl acetate, 2-methyl-1-propanol and propane-2-ol
AssayContent not less than 40 % and not more than 60 % of sucrose fatty acid esters
DescriptionSoft solid masses, stiff gels or white to off-white powders
A. Positive tests for sugar and for fatty acids
B. SolubilityInsoluble in cold waterSoluble in ethanol
Sulphated ashNot more than 2 % determined at 800 ± 25 °C
Free sugarNot more than 5 %
Free fatty acidsNot more than 3 % estimated as oleic acid
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
MethanolNot more than 10 mg/kg
DimethylformamideNot more than 1 mg/kg
2-methyl-1-propanolCyclohexaneNot more than 10 mg/kg, single or in combination
Ethyl acetatePropane-2-olNot more than 350 mg/kg, single or in combination
Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)
SynonymsPolyglycerol fatty acid estersPolyglycerin esters of fatty acid esters
DefinitionPolyglycerol esters of fatty acids are produced by the esterification of polyglycerol with food fats and oils or with fatty acids occurring in foods fats and oils. The polyglycerol moiety is predominantly di-, tri- and tetraglycerol and contains not more than 10 % of polyglycerols equal to or higher than heptaglycerol
AssayContent of total fatty acid ester not less than 90 %
DescriptionLight yellow to amber, oily to very viscous liquids; light tan to medium brown, plastic or soft solids; and light tan to brown, hard, waxy solids
A. Positive tests for glycerol, for polyglycerols and for fatty acids
B. SolubilityThe esters range from very hydrophilic to very lipophilic, but as a class tend to be dispersible in water and soluble in organic solvents and oils
Sulphated ashNot more than 0,5 % determined at 800 ± 25 °C
Acids other than fatty acidsNot detectable
Free fatty acidsNot more than 6 % estimated as oleic acid
Total glycerol and polyglycerolNot less than 18 % and not more than 60 %
Free glycerol and polyglycerolNot more than 7 %
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)
SynonymsGlycerol esters of condensed castor oil fatty acidsPolyglycerol esters of polycondensed fatty acids from castor oilPolyglycerol esters of interesterified ricinoleic acidPGPR
DefinitionPolyglycerol polyricinoleate is prepared by the esterification of polyglycerol with condensed castor oil fatty acids
DescriptionClear, highly viscous liquid
A. SolubilityInsoluble in water and in ethanol.Soluble in ether, hydrocarbons and halogenated hydrocarbons
B. Positive tests for glycerol, polyglycerol and for ricinoleic acid
C. Refractive index [n]65Between 1,4630 and 1,4665
PolyglycerolsThe polyglycerol moiety shall be composed of not less than 75 % of di-, tri- and tetraglycerols and shall contain not more than 10 % of polyglycerols equal to or higher than heptaglycerol
Hydroxyl valueNot less than 80 and not more than 100
Acid valueNot more than 6
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
SynonymsPropylene glycol esters of fatty acids
DefinitionConsists of mixtures of propane-1,2-diol mono- and diesters of fatty acids occurring in food fats and oils. The alcohol moiety is exclusively propane-1,2-diol together with dimer and traces of trimer. Organic acids other than food fatty acids are absent.
AssayContent of total fatty acid ester not less than 85 %
DescriptionClear liquids or waxy white flakes, beads or solids having a bland odour
A. Positive tests for propylene glycol and for fatty acids
Sulphated ashNot more than 0,5 % determined at 800 ± 25 °C
Acids other than fatty acidsNot detectable
Free fatty acidsNot more than 6 % estimated as oleic acid
Total propane-1,2-diolNot less than 11 % and not more than 31 %
Free propane-1,2-diolNot more than 5 %
Dimer and trimer of propylene glycolNot more than 0,5 %
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)
SynonymsTOSOM
DefinitionThermally oxidised soya bean oil interacted with mono- and diglycerides of fatty acids is a complex mixture of esters of glycerol and fatty acids found in edible fat and fatty acids from thermally oxidised soya bean oil. It is produced by interaction and desodorisation under vacuum at 130 °C of 10 % of thermally oxidised soya bean oil and 90 % mono- and diglycerides of food fatty acids. Soya bean oil is exclusively made from natural strains of soya beans
DescriptionPale yellow to light brown a waxy or solid consistency
A. SolubilityInsoluble in water. Soluble in hot oil or fat
Melting range55—65 °C
Free fatty acidsNot more than 1,5 % estimated as oleic acid
Free glycerolNot more than 2 %
Total fatty acids83—90 %
Total glycerol16—22 %
Fatty acid methyl esters, not forming adduct with ureaNot more than 9 % of total fatty acid methyl esters
Fatty acids, insoluble in petroleum etherNot more than 2 % of total fatty acids
Peroxide valueNot more than 3
EpoxidesNot more than 0,03 % oxirane oxygen
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
SynonymsSodium stearoyl lactylateSodium stearoyl lactate
DefinitionA mixture of the sodium salts of stearoyl lactylic acids and its polymers and minor amounts of sodium salts of other related acids, manufactured by the reaction of stearic acid and lactic acid. Other food fatty acids may also be present, free or esterified, due to their presence in the stearic acid used
Chemical namesSodium di-2-stearoyl lactateSodium di(2-stearoyloxy)propionate
Einecs246-929-7
Chemical formula(major components)C21H39O4NaC19H35O4Na
DescriptionWhite or slightly yellowish powder or brittle solid with a characteristic odour
A. Positive tests for sodium, for fatty acids and for lactic acid
B. SolubilityInsoluble in water. Soluble in ethanol
SodiumNot less than 2,5 % and not more than 5 %
Ester valueNot less than 90 and not more than 190
Acid valueNot less than 60 and not more than 130
Total lactic acidNot less than 15 % and not more than 40 %
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
SynonymsCalcium stearoyl lactate
DefinitionA mixture of the calcium salts of stearoyl lactylic acids and its polymers and minor amounts of calcium salts of other related acids, manufactured by the reaction of stearic acid and lactic acid. Other food fatty acids may also be present, free or esterified, due to their presence in the stearic acid used
Chemical nameCalcium di-2-stearoyl lactateCalcium di(2-stearoyloxy)propionate
Einecs227-335-7
Chemical formulaC42H78O8CaC38H70O8Ca
DescriptionWhite or slightly yellowish powder or brittle solid with a characteristic odour
A. Positive tests for calcium, for fatty acids and for lactid acid
B. SolubilitySlightly soluble in hot water
CalciumNot less than 1 % and not more than 5,2 %
Ester valueNot less than 125 and not more than 190
Total lactic acidNot less than 15 % and not more than 40 %
Acid valueNot less than 50 and not more than 130
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
SynonymsStearyl palmityl tartrate
DefinitionProduct of the esterification of tartaric acid with commercial stearyl alcohol, which consists essentially of stearyl and palmityl alcohols. It consists mainly of diester, with minor amounts of monoester and of unchanged starting materials
Chemical nameDistearyl tartrateDipalmityl tartrate
Chemical formulaC38H74O6 to C40H78O6
Molecular weight627 to 655
AssayContent of total ester not less than 90 % corresponding to an ester value of not less than 163 and not more than 180
DescriptionCream-coloured unctuous solid (at 25 °C)
A. Positive tests for tartare
B. Melting rangeBetween 67 °C and 77 °C. After saponification the saturated long chain fatty alcohols have a melting range of 49 °C to 55 °C
Hydroxyl valueNot less than 200 and not more than 220
Acid valueNot more than 5,6
Total tartaric acid contentNot less than 18 % and not more than 35 %
Sulphated ashNot more than 0,5 % determined at 800 ± 25 °C
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Unsaponifiable matterNot less than 77 % and not more than 83 %
Iodine valueNot more than 4 (Wijs)
DefinitionA mixture of the partial esters of sorbitol and its anhydrides with edible, commercial stearic acid
Einecs215-664-9
AssayContent not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters
DescriptionLight, cream- to tan-coloured beads or flakes or a hard, waxy solid with a slight characteristic odour
A. SolubilitySoluble at temperatures above its melting point in toluene, dioxane, carbon tetrachloride, ether, methanol, ethanol and aniline; insoluble in petroleum ether and acetone; insoluble in cold water but dispersible in warm water; soluble with haze at temperatures above 50 °C in mineral oil and ethyl acetate
B. Congealing range50—52 °C
C. Infrared absorption spectrumCharacteristic of a partial fatty acid ester of a polyol
WaterNot more than 2 % (Karl Fischer method)
Sulphated ashNot more than 0,5 %
Acid valueNot more than 10
Saponification valueNot less than 147 and not more than 157
Hydroxyl valueNot less than 235 and not more than 260
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
DefinitionA mixture of the partial esters of sorbitol and its anhydrides with edible, commercial stearic acid
Einecs247-891-4
AssayContent not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters
DescriptionLight, cream- to tan-coloured beads or flakes or hard, waxy solid with a slight odour
A. SolubilitySlightly soluble in toluene, ether, carbon tetrachloride and ethyl acetate; dispersible in petroleum ether, mineral oil, vegetable oils, acetone and dioxane; insoluble in water, methanol and ethanol
B. Congealing range47—50 °C
C. Infrared absorption spectrumCharacteristic of a partial fatty acid ester of a polyol
WaterNot more than 2 % (Karl Fischer method)
Sulphated ashNot more than 0,5 %
Acid valueNot more than 15
Saponification valueNot less than 176 and not more than 188
Hydroxyl valueNot less than 66 and not more than 80
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
DefinitionA mixture of the partial esters of sorbitol and its anhydrides with edible, commercial lauric acid
Einecs215-663-3
AssayContent not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters
DescriptionAmber-coloured oily viscous liquid, light cream to tan-coloured beads or flakes or a hard, waxy solid with a slight odour
A. SolubilityDispersible in hot and cold water
B. Infrared absorption spectrumCharacteristic of a partial fatty acid ester of a polyol
WaterNot more than 2 % (Karl Fischer method)
Sulphated ashNot more than 0,5 %
Acid valueNot more than 7
Saponification valueNot less than 155 and not more than 170
Hydroxyl valueNot less than 330 and not more than 358
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
DefinitionA mixture of the partial esters of sorbitol and its anhydrides with edible, commercial oleic acid. Major constituent is 1,4-sorbitan monooleate. Other constituents include isosorbide monooleate, sorbitan dioleate and sorbitan trioleate
Einecs215-665-4
AssayContent not less than 95 % of a mixture of sorbitol, sorbitan and isosorbide esters
DescriptionAmber-coloured viscous liquid, light cream to tan-coloured beads or flakes or a hard, waxy solid with a slight characteristic odour
A. SolubilitySoluble at temperatures above its melting point in ethanol, ether, ethyl acetate, aniline, toluene, dioxane, petroleum ether and carbon tetrachloride. Insoluble in cold water, dispersible in warm water
B. Iodine valueThe residue of oleic acid, obtained from the saponification of the sorbitan monoleate in assay, has a iodine value between 80 and 100
WaterNot more than 2 % (Karl Fischer method)
Sulphated ashNot more than 0,5 %
Acid valueNot more than 8
Saponification valueNot less than 145 and not more than 160
Hydroxyl valueNot less than 193 and not more than 210
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
SynonymsSorbitan palmitate
DefinitionA mixture of the partial esters of sorbitol and its anhydrides with edible, commercial palmitic acid
Einecs247-568-8
AssayContent not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters
DescriptionLight cream to tan-coloured beads or flakes or a hard, waxy solid with a slight characteristic odour
A. SolubilitySoluble at temperatures above its melting point in ethanol, methanol, ether, ethyl acetate, aniline, toluene, dioxane, petroleum ether and carbon tetrachloride. Insoluble in cold water but dispersible in warm water
B. Congealing range45—47 °C
C. Infrared absorption spectrumCharacteristic of a partial fatty acid ester of polyol
WaterNot more than 2 % (Karl Fischer method)
Sulphate ashNot more than 0,5 %
Acid valueNot more than 7,5
Saponification valueNot less than 140 and not more than 150
Hydroxyl valueNot less than 270 and not more than 305
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
SynonymsSylvineSylvite
Chemical namePotassium chloride
Einecs231-211-8
Chemical formulaeKCl
Molecular weight74,56
AssayContent not less than 99 % on the dried basis
DescriptionColourless, elongated, prismatic or cubital crystals or white granular powder.Odourless
A. SolubilityFreely soluble in water. Insoluble in ethanol
B. Positive tests for potassium and for chloride
Loss on dryingNot more than 1 % (105 °C, 2 hours)
SodiumNegative test
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Chemical nameFerrous di-D-gluconate dihydrateIron(II) di-gluconate dihydrate
Einecs206-076-3
Chemical formulaeC12H22FeO14·2H2O
Molecular weight482,17
AssayContent not less than 95 % on the dried basis
DescriptionPale greenish-yellow to yellowish-grey powder or granules, which may have a faint odour of burnt sugar
A. SolubilitySoluble with slight heating in water. Practically insoluble in ethanol
B. Positive test for ferrous ion
C. Formation of phenylhydrazine derivative of gluconic acid positive
D. pH of a 10 % solutionBetween 4 and 5,5
Loss on dryingNot more than 10 % (105 °C, 16 hours)
Oxalic acidNot detectable
Iron (Fe III)Not more than 2 %
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Reducing substancesNot more than 0,5 % expressed as glucose
SynonymsIron(II) lactateIron(II) 2-hydroxy propanoatePropanoic acid, 2-hydroxy-iron(2 +) salt (2:1)
Chemical nameFerrous 2-hydroxy propanoate
Einecs227-608-0
Chemical formulaeC6H10FeO6·xH2O (x = 2 or 3)
Molecular weight270,02 (dihydrate)288,03 (trihydrate)
AssayContent not less than 96 % on the dried basis
DescriptionGreenish-white crystals or light green powder having a characteristic smell
A. SolubilitySoluble in water. Practically insoluble in ethanol
B. Positive test for ferrous ion and for lactate
C. pH of a 2 % solutionBetween 4 and 6
Loss on dryingNot more than 18 % (100 °C, under vacuum, approximately 700 mm Hg)
Iron (Fe III)Not more than 0,6 %
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
SynonymsAcetic acid, zinc salt, dihydrate
Chemical nameZinc acetate dihydrate
Chemical formulaC4H6O4 Zn · 2H2O
Molecular weight219,51
AssayContent not less than 98 % and not more than 102 % of C4H6O4 Zn · 2H2O
DescriptionColourless crystals or fine, off-white powder
A.Positive tests for acetate and for zinc
B.pH of a 5 % solutionBetween 6,0 and 8,0
Insoluble matterNot more than 0,005 %
ChloridesNot more than 50 mg/kg
SulphatesNot more than 100 mg/kg
Alkalines and alkaline earthsNot more than 0,2 %
Organic volatile impuritiesPasses test
IronNot more than 50 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 20 mg/kg
CadmiumNot more than 5 mg/kg
Synonymsn-Butane
Chemical nameButane
Chemical formulaCH3CH2CH2CH3
Molecular weight58,12
AssayContent not less than 96 %
DescriptionColourless gas or liquid with mild, characteristic odour
A.Vapour pressure108,935 kPa at 20 °C
MethaneNot more than 0,15 % v/v
EthaneNot more than 0,5 % v/v
PropaneNot more than 1,5 % v/v
IsobutaneNot more than 3,0 % v/v
1,3-butadieneNot more than 0,1 % v/v
MoistureNot more than 0,005 %
Synonyms2-methyl propane
Chemical name2-methyl propane
Chemical formula(CH3)2CH CH3
Molecular weight58,12
AssayContent not less than 94 %
DescriptionColourless gas or liquid with mild, characteristic odour
A.Vapour pressure205,465 kPa at 20 °C
MethaneNot more than 0,15 % v/v
EthaneNot more than 0,5 % v/v
PropaneNot more than 2,0 % v/v
n-ButaneNot more than 4,0 % v/v
1,3-butadieneNot more than 0,1 % v/v
MoistureNot more than 0,005 %
Chemical namePropane
Chemical formulaCH3CH2CH3
Molecular weight44,09
AssayContent not less than 95 %
DescriptionColourless gas or liquid with mild, characteristic odour
A.Vapour pressure732,910 kPa at 20 °C
MethaneNot more than 0,15 % v/v
EthaneNot more than 1,5 % v/v
IsobutaneNot more than 2,0 % v/v
n-ButaneNot more than 1,0 % v/v
1,3-butadieneNot more than 0,1 % v/v
MoistureNot more than 0,005 %
Chemical nameHydrogen
Einecs215-605-7
Chemical formulaH2
Molecular weight2
AssayContent not less than 99,9 %
DescriptionColourless, odourless, highly flammable gas
WaterNot more than 0,005 % v/v
OxygenNot more than 0,001 % v/v
NitrogenNot more than 0,75 % v/v
SynonymsLysozyme hydrochlorideMuramidase
DefinitionLysozyme is a linear polypeptide obtained from hens' egg whites consisting of 129 amino acids. It possesses enzymatic activity in its ability to hydrolyse the β(1-4) linkages between N-acetylmuramic acid and N-acetylglucosamine in the outer membranes of bacterial species, in particular gram-positive organisms. Is usually obtained as the hydrochloride
Chemical nameEnzyme Commission (EC) No: 3.2.1.17
Einecs232-620-4
Molecular weightAbout 14000
AssayContent not less than 950 mg/g on the anhydrous basis
DescriptionWhite, odourless powder having a slightly sweet taste
A. Isoelectric point 10,7
B. pH of a 2 % aqueous solution between 3,0 and 3,6
C. Absorption maximum of an aqueous solution (25 mg/100 ml) at 281 nm, a minimum at 252 nm
Water contentNot more than 6,0 % (Karl Fischer method) (powder form only)
Residue on ignitionNot more than 1,5 %
NitrogenNot less than 16,8 % and not more than 17,8 %
ArsenicNot more than 1 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Total bacterial countNot more than 5 × 104 col/g
SalmonellaeAbsent in 25 g
Staphylococcus aureusAbsent in 1 g
Escherichia coliAbsent in 1 g
SynonymsPovidonePVPSoluble polyvinylpyrrolidone
Chemical namePolyvinylpyrrolidone, poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene]
Chemical formula(C6H9NO)n
Molecular weightNot less than 25000
AssayContent not less than 11,5 % and not more than 12,8 % of nitrogen (N) on the anhydrous basis
DescriptionWhite or nearly white powder
A.SolubilitySoluble in water and in ethanol. Insoluble in ether
B.pH of a 5 % solutionBetween 3,0 and 7,0
WaterNot more than 5 % (Karl Fischer)
Total ashNot more than 0,1 %
AldehydeNot more than 500 mg/kg (as acetaldehyde)
Free-N-vinylpyrrolidoneNot more than 10 mg/kg
HydrazineNot more than 1 mg/kg
LeadNot more than 5 mg/kg
SynonymsCrospovidoneCross linked polyvidoneInsoluble polyvinylpyrrolidone
DefinitionPolyvinylpolypyrrolidone is a poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene], cross linked in a random fashion. It is produced by the polymerisation of N-vinyl-2-pyrrolidone in the presence of either caustic catalyst or N, N'-divinyl-imidazolidone. Due to its insolubility in all common solvents the molecular weight range is not amenable to analytical determination
Chemical namePolyvinylpyrrolidone, poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene]
Chemical formula(C6H9NO)n
AssayContent not less than 11 % and not more than 12,8 % nitrogen (N) on the anhydrous basis
DescriptionA white hygroscopic powder with a faint, non-objectionable odour
A.SolubilityInsoluble in water, ethanol and ether
B.pH of a 1 % suspension in waterBetween 5,0 and 8,0
WaterNot more than 6 % (Karl Fischer)
Sulphated ashNot more than 0,4 %
Water-soluble matterNot more than 1 %
Free-N-vinylpyrrolidoneNot more than 10 mg/kg
Free-N,N'-divinyl-imidazolidoneNot more than 2 mg/kg
LeadNot more than 5 mg/kg
SynonymsPEG 6000
Macrogol 6000
DefinitionPolyethylene glycol 6000 is a mixture of polymers with the general formula H — (OCH2 — CH) — OH corresponding to an average relative molecular mass of approximately 6000
Chemical formula(C2H4O)n H2O (n = number of ethylene oxide units corresponding to a molecular weight of 6000, about 140)
Molecular weight56007000
AssayNot less than 90,0 % and not more than 110,0 %
DescriptionA white or almost white solid with a waxy or paraffin-like appearance
A.SolubilityVery soluble in water and in methylene chloride. Practically insoluble in alcohol, in ether and in fatty and mineral oils
B.Melting rangeBetween 55 °C and 61 °C
ViscosityBetween 0,220 and 0,275 kgm-1s-1 at 20 °C
Hydroxyl valueBetween 16 and 22
Sulphated ashNot more than 0,2 %
Ethylene oxideNot more than 0,2 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
SynonymsDL-Malic acid, pomalous acid
Chemical nameDL-Malic acid, hydroxybutanedioic acid, hydroxysuccinic acid
Einecs230-022-8
Chemical formulaC4H6O5
Molecular weight134,09
AssayContent not less than 99,0 %
DescriptionWhite or nearly white crystalline powder or granules
A.Melting range between 127 °C and 132 °CB.Positive test for malateC.Solutions of this substance are optically inactive in all concentrations
Sulphated ashNot more than 0,1 %
Fumaric acidNot more than 1,0 %
Maleic acidNot more than 0,05 %
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Chemical nameTrans-butenedioic acid, trans-1,2-ethylene-dicarboxylic acid
Einecs203-743-0
Chemical formulaC4H4O4
Molecular weight116,07
AssayContent not less than 99,0 % on the anhydrous basis
DescriptionWhite crystalline powder or granules
A.Melting range286 °C - 302 °C (closed capillary, rapid heating)
B.Positive tests for double bonds and for 1,2-dicarboxylic acid
C.pH of a 0,05 % solution at 25 °C3,0 - 3,2
Loss on dryingNot more than 0,5 % (120 °C, 4h)
Sulphated ashNot more than 0,1 %
Maleic acidNot more than 0,1 %
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
SynonymsMagnesiumdihydrogenphosphateMagnesiumphosphate, monobasicMonomagnesium orthophosphate
Chemical nameMonomagnesiumdihydrogenmonophosphate
Einecs236-004-6
Chemical formulaMgH2PO42 · nH2O (where n = 0 to 4)
Molecular weight218,30 (anhydrous)
AssayNot less than 51,0 % after ignition
DescriptionWhite, odourless, crystalline powder, slightly soluble in water
A.Positive test for magnesium and for phosphate
B.MgO contentNot less than 21,5 % after ignition
FluorideNot more than 10 mg/kg (as fluorine)
ArsenicNot more than 3 mg/kg
LeadNot more than 4 mg/kg
CadmiumNot more than 1 mg/kg
MercuryNot more than 1 mg/kg
SynonymsMagnesiumhydrogenphosphateMagnesiumphosphate, dibasicDimagnesium orthophosphateSecondary magnesiumphosphate
Chemical nameDimagnesiummonohydrogenmonophosphate
Einecs231-823-5
Chemical formulaMgHPO4 · nH2O (where n = 0 - 3)
Molecular weight120,30 (anhydrous)
AssayNot less than 96 % after ignition
DescriptionWhite, odourless, crystalline powder, slightly soluble in water
A.Positive test for magnesium and for phosphate
B.MgO content:Not less than 33,0 % calculated on an anhydrous basis
FluorideNot more than 10 mg/kg (as fluorine)
ArsenicNot more than 3 mg/kg
LeadNot more than 4 mg/kg
CadmiumNot more than 1 mg/kg
MercuryNot more than 1 mg/kg
SynonymsSodium salt of malic acid
Chemical nameDisodium DL-malate, disodium salt of hydroxybutanedioic acid
Chemical formulaHemihydrate:C4H4Na2O5 · ½ H2OTrihydrate:C4H4Na2O5 · 3H2O
Molecular weightHemihydrate: 187,05Trihydrate: 232,10
AssayContent not less than 98,0 % on the anhydrous basis
DescriptionWhite crystalline powder or lumps
A.Positive tests for 1,2-dicarboxylic acid and for sodium
B.Azo dye formationPositive
C.SolubilityFreely soluble in water
Loss on dryingNot more than 7,0 % (130 °C, 4h) for the hemihydrate, or 20,5 % - 23,5 % (130 °C, 4h) for the trihydrate
AlkalinityNot more than 0,2 % asNa2CO3
Fumaric acidNot more than 1,0 %
Maleic acidNot more than 0,05 %
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
SynonymsMonosodium salt of DL-malic acid
Chemical nameMonosodium DL-malate, monosodium 2-DL-hydroxy succinate
Chemical formulaC4H5NaO5
Molecular weight156,07
AssayContent not less than 99,0 % on the anhydrous basis
DescriptionWhite powder
A.Positive tests for 1,2-dicarboxylic acid and for sodium
B.Azo dye formationPositive
Loss on dryingNot more than 2,0 % (110 °C, 3h)
Maleic acidNot more than 0,05 %
Fumaric acidNot more than 1,0 %
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
SynonymsPotassium salt of malic acid
Chemical nameDipotassium DL-malate, dipotassium salt of hydroxybutanedioic acid
Chemical formulaC4H4K2O5
Molecular weight210,27
AssayContent not less than 59,5 %
DescriptionColourless or almost colourless aqueous solution
A.Positive tests for 1,2-dicarboxylic acid and for potassium
B.Azo dye formationPositive
AlkalinityNot more than 0,2 % asK2CO3
Fumaric acidNot more than 1,0 %
Maleic acidNot more than 0,05 %
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
SynonymsCalcium salt of malic acid
Chemical nameCalcium DL-malate, calcium-α-hydroxysuccinate, calcium salt of hydroxybutanedioic acid
Chemical formulaC4H5CaO5
Molecular weight172,14
AssayContent not less than 97,5 % on the anhydrous basis
DescriptionWhite powder
A.Positive tests for malate, 1,2-dicarboxylic acid and for calcium
B.Azo dye formationPositive
C.SolubilitySlightly soluble in water
Loss on dryingNot more than 2 % (100 °C, 3h)
AlkalinityNot more than 0,2 % asCaCO3
Maleic acidNot more than 0,05 %
Fumaric acidNot more than 1,0 %
FluorideNot more than 30 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
SynonymsMonocalcium salt of DL-malic acid
Chemical nameMonocalcium DL-malate, monocalcium 2-DL-hydroxysuccinate
Chemical formulaC4H5O52Ca
AssayContent not less than 97,5 % on the anhydrous basis
DescriptionWhite powder
A.Positive tests for 1,2-dicarboxylic acid and for calcium
B.Azo dye formationPositive
Loss on dryingNot more than 2,0 % (110 °C, 3h)
Maleic acidNot more than 0,05 %
Fumaric acidNot more than 1,0 %
FluorideNot more than 30 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Chemical nameHexanedioic acid, 1,4-butanedicarboxylic acid
EINECS204-673-3
Chemical formulaC6H10O4
Molecular weight146,14
AssayContent not less than 99,6 %
DescriptionWhite odourless crystals or crystalline powder
A.Melting range151,5-154,0 °C
B.SolubilitySlightly soluble in water. Freely soluble in ethanol
WaterNot more than 0,2 % (Karl Fischer method)
Sulphated ashNot more than 20 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Chemical nameButanedioic acid
EINECS203-740-4
Chemical formulaC4H6O4
Molecular weight118,09
AssayContent no less than 99,0 %
DescriptionColourless or white, odourless crystals
A.Melting rangeBetween 185,0 °C and 190,0 °C
Residue on ignitionNot more than 0,025 % (800 °C, 15 min)
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
SynonymsTribasic ammonium citrate
Chemical nameTriammonium salt of 2-hydroxypropan-1,2,3-tricarboxylic acid
EINECS222-394-5
Chemical formulaC6H17N3O7
Molecular weight243,22
AssayContent not less than 97,0 %
DescriptionWhite to off-white crystals or powder
A.Positive tests for ammonium and for citrate
B.SolubilityFreely soluble in water
OxalateNot more than 0,04 % (as oxalic acid)
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
SynonymSodium calcium polyphosphate, glassy
Chemical nameSodium calcium polyphosphate
EINECS233-782-9
Chemical formulaNaPO3n CaO where n is typically 5
AssayNot less than 61 % and not more than 69 % asP2O5
DescriptionWhite glassy crystals, spheres
A.pH of a 1 % m/m slurryApproximately 5 to 7
B.CaO content7 %-15 % m/m
FluorideNot more than 10 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 4 mg/kg
CadmiumNot more than 1 mg/kg
MercuryNot more than 1 mg/kg
DefinitionBeta-cyclodextrin is a non-reducing cyclic saccharide consisting of seven α-1,4-linked D-glucopyranosyl units. The product is manufactured by the action of the enzyme cycloglycosyltransferase (CGTase) obtained from Bacillus circulans, Paenibacillus macerans or recombinant Bacillus licheniformis strain SJ1608 on partially hydrolysed starch.
Chemical nameCycloheptaamylose
EINECS231-493-2
Chemical formula(C6H10O5)7
Molecular weight1135
AssayContent not less than 98,0 % of (C6H10O5)7 on an anhydrous basis
DescriptionVirtually odourless white or almost white crystalline solid
A.SolubilitySparingly soluble in water; freely soluble in hot water; slightly soluble in ethanol
B.Specific rotation[α] 25D: +160 ° to +164 ° (1 % solution)
WaterNot more than 14 % (Karl Fischer method)
Other cyclodextrinsNot more than 2 % on an anhydrous basis
Residual solvents (toluene and trichloroethylene)Not more than 1 mg/kg for each solvent
Sulphated ashNot more than 0,1 %
ArsenicNot more than 1 mg/kg
LeadNot more than 1 mg/kg
SynonymsCross-linked carboxymethyl celluloseCross-linked CMCCross-linked sodium CMCCross-linked cellulose gum
DefinitionCross-linked sodium carboxymethyl cellulose is the sodium salt of thermally cross-linked partly O-carboxymethylated cellulose
Chemical nameSodium salt of the cross-linked carboxymethyl ether cellulose
Chemical formulaThe polymers containing substituted anhydroglucose units with the general formula:C6H7O2OR1OR2OR3whereR1,R2 andR3 may be any of the following:HCH2COONaCH2COOH
DescriptionSlightly hygroscopic, white to off white, odourless powder
A.Shake 1 g with 100 ml of a solution containing 4 mg/kg methylene blue and allow to settle. The substance to be examined absorbs the methylene blue and settles as a blue, fibrous mass
B.Shake 1 g with 50 ml of water. Transfer 1 ml of the mixture to a test tube, add 1 ml water and 0,05 ml of freshly prepared 40 g/l solution of alpha-naphthol in methanol. Incline the test tube and add carefully 2 ml of sulphuric acid down the side so that it forms a lower layer. A reddish-violet colour develops at the interface
C.It gives the reaction of sodium
Loss on dryingNot more than 6 % (105 °C, 3h)
Water solublesNot more than 10 %
Degree of substitutionNot less than 0,2 and not more than 1,5 carboxymethyl groups per anhydroglucose unit
pH of 1 %Not less than 5,0 and not more than 7,0
Sodium contentNot more than 12,4 % on anhydrous basis
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
CadmiumNot more than 1 mg/kg
MercuryNot more than 1 mg/kg
SynonymsSodium carboxymethyl cellulose, enzymatically hydrolysed
DefinitionEnzymatically hydrolysed carboxymethylcellulose is obtained from carboxymethylcellulose by enzymatic digestion with a cellulase produced by Trichoderma longibrachiatum (formerly T. reesei)
Chemical nameCarboxymethyl cellulose, sodium, partially enzymatically hydrolysed
Chemical formulaSodium salts of polymers containing substituted anhydroglucose units with the general formula:C6H7O2OHxOCH2COONaynwhere n is the degree of polymerisationx = 1,50 to 2,80y = 0,2 to 1,50x + y = 3,0(y = degree of substitution)
Formula weight178,14 where y = 0,20282,18 where y = 1,50Macromolecules: Not less than 800 (n about 4)
AssayNot less than 99,5 %, including mono- and disaccharides, on the dried basis
DescriptionWhite or slightly yellowish or greyish, odourless, slightly hygroscopic granular or fibrous powder
A.SolubilitySoluble in water, insoluble in ethanol
B.Foam testVigorously shake a 0,1 % solution of the sample. No layer of foam appears. This test distinguishes sodium carboxymethyl cellulose, whether hydrolysed or not, from other cellulose ethers and from alginates and natural gums
C.Precipitate formationTo 5 ml of a 0,5 % solution of the sample add 5 ml of a 5 % solution of copper or aluminium sulphate. A precipitate appears. This test distinguishes sodium carboxymethyl cellulose, whether hydrolysed or not, from other cellulose ethers and from gelatine, carob bean gum and tragacanth gum
D.Colour reactionAdd 0,5 g of the powdered sample to 50 ml of water, while stirring to produce a uniform dispersion. Continue the stirring until a clear solution is produced. Dilute 1 ml of the solution with 1 ml of water in a small test tube. Add 5 drops of 1-naphthol TS. Incline the tube, and carefully introduce down the side of the tube 2 ml of sulphuric acid so that it forms a lower layer. A red-purple colour develops at the interface
E.Viscosity (60 % solids)Not less than 2,500 kgm-1s-1 at 25 °C corresponding to an average molecule weight of 5000 D
Loss on dryingNot more than 12 % (105 °C to constant weight)
Degree of substitutionNot less than 0,2 and not more than 1,5 carboxymethyl groups per anhydroglucose unit on the dried basis
pH of a 1 % colloidal solutionNot less than 6,0 and not more than 8,5
Sodium chloride and sodium glycolateNot more than 0,5 % singly or in combination
Residual enzyme activityPasses test. No change in viscosity of test solution occurs, which indicates hydrolysis of the sodium carboxymethyl cellulose
LeadNot more than 3 mg/kg
SynonymsSoda ash
Chemical nameSodium carbonate
EINECS207-838-8
Chemical formulaNa2CO3 · nH2O (n = 0, 1 or 10)
Molecular weight106,00 (anhydrous)
AssayContent not less than 99 % ofNa2CO3 on the anhydrous basis
DescriptionColourless crystals or white, granular or crystalline powderThe anhydrous form is hygroscopic, the decahydrate efflorescent
A.Positive tests for sodium and for carbonate
B.SolubilityFreely soluble in water. Insoluble in ethanol
Loss on dryingNot more than 2 % (anhydrous), 15 % (monohydrate) or 55 %-65 % (decahydrate) (70 °C raising gradually to 300 °C, to constant weight)
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
SynonymsSodium bicarbonate, sodium acid carbonate, bicarbonate of soda, baking soda
Chemical nameSodium hydrogen carbonate
EINECS205-633-8
Chemical formulaNaHCO3
Molecular weight84,01
AssayContent not less than 99 % on the anhydrous basis
DescriptionColourless or white crystalline masses or crystalline powder
A.Positive tests for sodium and for carbonate
B.pH of a 1 % solutionBetween 8,0 and 8,6
C.SolubilitySoluble in water. Insoluble in ethanol
Loss on dryingNot more than 0,25 % (over silica gel, 4h)
Ammonium saltsNo odour of ammonia detectable after heating
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Chemical nameSodium monohydrogen dicarbonate
EINECS208-580-9
Chemical formulaNa2CO3 · NaHCO3 · 2H2O
Molecular weight226,03
AssayContent between 35,0 % and 38,6 % ofNaHCO3 and between 46,4 % and 50,0 % ofNa2CO3
DescriptionWhite flakes, crystals or crystalline powder
A.Positive tests for sodium and for carbonate
B.SolubilityFreely soluble in water
Sodium chlorideNot more than 0,5 %
IronNot more than 20 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Chemical namePotassium carbonate
EINECS209-529-3
Chemical formulaK2CO3 · nH2O (n = 0 or 1,5)
Molecular weight138,21 (anhydrous)
AssayContent not less than 99,0 % on the anhydrous basis
DescriptionWhite, very deliquescent powder.The hydrate occurs as small, white, translucent crystals or granules
A.Positive tests for potassium and for carbonate
B.SolubilityVery soluble in water. Insoluble in ethanol
Loss on dryingNot more than 5 % (anhydrous) or 18 % (hydrate) (180 °C, 4h)
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
SynonymsPotassium bicarbonate, acid potassium carbonate
Chemical namePotassium hydrogen carbonate
EINECS206-059-0
Chemical formulaKHCO3
Molecular weight100,11
AssayContent not less than 99,0 % and not more than 101,0 %KHCO3 on the anhydrous basis
DescriptionColourless crystals or white powder or granules
A.Positive tests for potassium and for carbonate
B.SolubilityFreely soluble in water. Insoluble in ethanol
Loss on dryingNot more than 0,25 % (over silica gel, 4h)
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
DefinitionAmmonium carbonate consists of ammonium carbamate, ammonium carbonate and ammonium hydrogen carbonate in varying proportions
Chemical nameAmmonium carbonate
EINECS233-786-0
Chemical formulaCH6N2O2,CH8N2O3 andCH5NO3
Molecular weightAmmonium carbamate 78,06; ammonium carbonate 98,73; ammonium hydrogen carbonate 79,06
AssayContent not less than 30,0 % and not more than 34,0 % ofNH3
DescriptionWhite powder or hard, white or translucent masses or crystals. Becomes opaque on exposure to air and is finally converted into white porous lumps or powder (of ammonium bicarbonate) due to loss of ammonia and carbon dioxide
A.Positive tests for ammonium and for carbonateB.pH of a 5 % solution about 8,6
C.SolubilitySoluble in water
Non-volatile matterNot more than 500 mg/kg
ChloridesNot more than 30 mg/kg
SulphateNot more than 30 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
SynonymsAmmonium bicarbonate
Chemical nameAmmonium hydrogen carbonate
EINECS213-911-5
Chemical formulaCH5NO3
Molecular weight79,06
AssayContent not less than 99,0 %
DescriptionWhite crystals or crystalline powder
A.Positive tests for ammonium and for carbonateB.pH of a 5 % solution about 8,0
C.SolubilityFreely soluble in water. Insoluble in ethanol
Non-volatile matterNot more than 500 mg/kg
ChloridesNot more than 30 mg/kg
SulphateNot more than 30 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
SynonymsHydrogen chloride, muriatic acid
Chemical nameHydrochloric acid
EINECS231-595-7
Chemical formulaHCl
Molecular weight36,46
AssayHydrochloric acid is commercially available in varying concentrations. Concentrated hydrochloric acid contains not less than 35,0 % HCl
DescriptionClear, colourless or slightly yellowish, corrosive liquid having a pungent odour
A.Positive tests for acid and for chloride
B.SolubilitySoluble in water and in ethanol
Total organic compoundsTotal organic compounds (non-fluorine containing): not more than 5 mg/kgBenzene: not more than 0,05 mg/kgFluorinated compounds (total): not more than 25 mg/kg
Non-volatile matterNot more than 0,5 %
Reducing substancesNot more than 70 mg/kg (asSO2)
Oxidising substancesNot more than 30 mg/kg (asCl2)
SulphateNot more than 0,5 %
IronNot more than 5 mg/kg
ArsenicNot more than 1 mg/kg
LeadNot more than 1 mg/kg
MercuryNot more than 1 mg/kg
Chemical nameCalcium chloride
EINECS233-140-8
Chemical formulaCaCl2 · nH2O (n = 0,2 or 6)
Molecular weight110,99 (anhydrous), 147,02 (dihydrate), 219,08 (hexahydrate)
AssayContent not less than 93,0 % on the anhydrous basis
DescriptionWhite, odourless, hygroscopic powder or deliquescent crystals
A.Positive tests for calcium and for chloride
B.SolubilityAnhydrous calcium chloride: freely soluble in water and ethanolDihydrate: freely soluble in water, soluble in ethanolHexahydrate: very soluble in water and ethanol
Magnesium and alkali saltsNot more than 5 % on the anhydrous basis
FluorideNot more than 40 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
Chemical nameMagnesium chloride
EINECS232-094-6
Chemical formulaMgCl2 · 6H2O
Molecular weight203,30
AssayContent not less than 99,0 %
DescriptionColourless, odourless, very deliquescent flakes or crystals
A.Positive tests for magnesium and for chloride
B.SolubilityVery soluble in water, freely soluble in ethanol
AmmoniumNot more than 50 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
SynonymsTin chloride, tin dichloride
Chemical nameStannous chloride dihydrate
EINECS231-868-0
Chemical formulaSnCl2 · 2H2O
Molecular weight225,63
AssayContent not less than 98,0 %
DescriptionColourless or white crystalsMay have a slight odour of hydrochloric acid
A.Positive tests for tin (II) and for chloride
B.SolubilityWater: soluble in less than its own weight of water, but it forms an insoluble basic salt with excess waterEthanol: soluble
SulphateNot more than 30 mg/kg
ArsenicNot more than 2 mg/kg
MercuryNot more than 1 mg/kg
LeadNot more than 5 mg/kg
SynonymsOil of vitriol, dihydrogen sulphate
Chemical nameSulphuric acid
EINECS231-639-5
Chemical formulaH2SO4
Molecular weight98,07
AssaySulphuric acid is commercially available in varying concentrations. The concentrated form contains not less than 96,0 %
DescriptionClear, colourless or slightly brown, very corrosive oily liquid
A.Positive tests for acid and for sulphate
B.SolubilityMiscible with water, with generation of much heat, also with ethanol
AshNot more than 0,02 %
Reducing matterNot more than 40 mg/kg (asSO2)
NitrateNot more than 10 mg/kg (onH2SO4 basis)
ChlorideNot more than 50 mg/kg
IronNot more than 20 mg/kg
SeleniumNot more than 20 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Chemical nameSodium sulphate
Chemical formulaNa2SO4 · nH2O (n = 0 or 10)
Molecular weight142,04 (anhydrous)322,04 (decahydrate)
AssayContent not less than 99,0 % on the anhydrous basis
DescriptionColourless crystals or a fine, white, crystalline powderThe decahydrate is efflorescent
A.Positive tests for sodium and for sulphateB.Acidity of a 5 % solution: neutral or slightly alkaline to litmus paper
Loss on dryingNot more than 1,0 % (anhydrous) or not more than 57 % (decahydrate) at 130 °C
SeleniumNot more than 30 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
SynonymsAcid sodium sulphate, sodium bisulphate, nitre cake
Chemical nameSodium hydrogen sulphate
Chemical formulaNaHSO4
Molecular weight120,06
AssayContent not less than 95,2 %
DescriptionWhite, odourless crystals or granules
A.Positive tests for sodium and for sulphateB.Solutions are strongly acidic
Loss on dryingNot more than 0,8 %
Water insolubleNot more than 0,05 %
SeleniumNot more than 30 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Chemical namePotassium sulphate
Chemical formulaK2SO4
Molecular weight174,25
AssayContent not less than 99,0 %
DescriptionColourless or white crystals or crystalline powder
A.Positive tests for potassium and for sulphate
B.pH of a 5 % solutionBetween 5,5 and 8,5
C.SolubilityFreely soluble in water, insoluble in ethanol
SeleniumNot more than 30 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
SynonymsPotassium bisulphate, potassium acid sulphate
Chemical namePotassium hydrogen sulphate
Chemical formulaKHSO4
Molecular weight136,17
AssayContent not less than 99 %
Melting point197 °C
DescriptionWhite deliquescent crystals, pieces or granules
A.Positive test for potassium
B.SolubilityFreely soluble in water, insoluble in ethanol
SeleniumNot more than 30 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
SynonymsGypsum, selenite, anhydrite
Chemical nameCalcium sulphate
EINECS231-900-3
Chemical formulaCaSO4 · nH2O (n = 0 or 2)
Molecular weight136,14 (anhydrous), 172,18 (dihydrate)
AssayContent not less than 99,0 % on the anhydrous basis
DescriptionFine, white to slightly yellowish-white odourless powder
A.Positive tests for calcium and for sulphate
B.SolubilitySlightly soluble in water, insoluble in ethanol
Loss on dryingAnhydrous: not more than 1,5 % (250 °C, constant weight)Dihydrate: not more than 23 % (ibid.)
FluorideNot more than 30 mg/kg
SeleniumNot more than 30 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Chemical nameAmmonium sulphate
EINECS231-984-1
Chemical formulaNH42SO4
Molecular weight132,14
AssayContent not less than 99,0 % and not more than 100,5 %
DescriptionWhite powder, shining plates or crystalline fragments
A.Positive tests for ammonium and for sulphate
B.SolubilityFreely soluble in water, insoluble in ethanol
Loss on ignitionNot more than 0,25 %
SeleniumNot more than 30 mg/kg
LeadNot more than 5 mg/kg
SynonymsAlum
Chemical nameAluminium sulphate
EINECS233-135-0
Chemical formulaAl2SO43
Molecular weight342,13
AssayContent not less than 99,5 % on the ignited basis
DescriptionWhite powder, shining plates or crystalline fragments
A.Positive tests for aluminium and for sulphateB.pH of a 5 % solution 2,9 or above
C.SolubilityFreely soluble in water, insoluble in ethanol
Loss on ignitionNot more than 5 % (500 °C, 3h)
Alkalies and alkaline earthsNot more than 0,4 %
SeleniumNot more than 30 mg/kg
FluorideNot more than 30 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
SynonymsSoda alum, sodium alum
Chemical nameAluminium sodium sulphate
EINECS233-277-3
Chemical formulaAlNaSO42 · nH2O (n = 0 or 12)
Molecular weight242,09 (anhydrous)
AssayContent on the anhydrous basis not less than 96,5 % (anhydrous) and 99,5 % (dodecahydrate)
DescriptionTransparent crystals or white crystalline powder
A.Positive tests for aluminium, for sodium and for sulphate
B.SolubilityDodecahydrate is freely soluble in water. The anhydrous form is slowly soluble in water. Both forms are insoluble in ethanol
Loss on dryingAnhydrous form: not more than 10,0 % (220 °C, 16h)Dodecahydrate: not more than 47,2 % (50 °C-55 °C, 1h then 200 °C, 16h)
Ammonium saltsNo odour of ammonia detectable after heating
SeleniumNot more than 30 mg/kg
FluorideNot more than 30 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
SynonymsPotassium alum, potash alum
Chemical nameAluminium potassium sulphate dodecahydrate
EINECS233-141-3
Chemical formulaAlKSO42 · 12 H2O
Molecular weight474,38
AssayContent not less than 99,5 %
DescriptionLarge, transparent crystals or white crystalline powder
A.Positive tests for aluminium, for potassium and for sulphateB.pH of a 10 % solution between 3,0 and 4,0
C.SolubilityFreely soluble in water, insoluble in ethanol
Ammonium saltsNo odour of ammonia detectable after heating
SeleniumNot more than 30 mg/kg
FluorideNot more than 30 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
SynonymsAmmonium alum
Chemical nameAluminium ammonium sulphate
EINECS232-055-3
Chemical formulaAlNH4SO42 · 12 H2O
Molecular weight453,32
AssayContent not less than 99,5 %
DescriptionLarge, colourless crystals or white powder
A.Positive tests for aluminium, for ammonium and for sulphate
B.SolubilityFreely soluble in water, soluble in ethanol
Alkali metals and alkaline earthsNot more than 0,5 %
SeleniumNot more than 30 mg/kg
FluorideNot more than 30 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
SynonymsCaustic soda, lye
Chemical nameSodium hydroxide
EINECS215-185-5
Chemical formulaNaOH
Molecular weight40,0
AssayContent of solid forms not less than 98,0 % of total alkali (as NaOH). Content of solutions accordingly, based on the stated or labelled percentage of NaOH
DescriptionWhite or nearly white pellets, flakes, sticks, fused masses or other forms. Solutions are clear or slightly turbid, colourless or slightly coloured, strongly caustic and hygroscopic and when exposed to the air they absorb carbon dioxide, forming sodium carbonate
A.Positive tests for sodiumB.A 1 % solution is strongly alkaline
C.SolubilityVery soluble in water. Freely soluble in ethanol
Water insoluble and organic matterA 5 % solution is completely clear and colourless to slightly coloured
CarbonateNot more than 0,5 % (asNa2CO3)
ArsenicNot more than 3 mg/kg
LeadNot more than 0,5 mg/kg
MercuryNot more than 1 mg/kg
SynonymsCaustic potash
Chemical namePotassium hydroxide
EINECS215-181-3
Chemical formulaKOH
Molecular weight56,11
AssayContent not less than 85,0 % of alkali calculated as KOH
DescriptionWhite or nearly white pellets, flakes, sticks, fused masses or other forms
A.Positive tests for potassiumB.A 1 % solution is strongly alkaline
C.SolubilityVery soluble in water. Freely soluble in ethanol
Water insoluble matterA 5 % solution is completely clear and colourless
CarbonateNot more than 3,5 % (asK2CO3)
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
SynonymsSlaked lime, hydrated lime
Chemical nameCalcium hydroxide
EINECS215-137-3
Chemical formulaCaOH2
Molecular weight74,09
AssayContent not less than 92,0 %
DescriptionWhite powder
A.Positive tests for alkali and for calcium
B.SolubilitySlightly soluble in water. Insoluble in ethanol. Soluble in glycerol
Acid insoluble ashNot more than 1,0 %
Magnesium and alkali saltsNot more than 1,0 %
BariumNot more than 300 mg/kg
FluorideNot more than 50 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
SynonymsAqua ammonia, strong ammonia solution
Chemical nameAmmonium hydroxide
Chemical formulaNH4OH
Molecular weight35,05
AssayContent not less than 27 % ofNH3
DescriptionClear, colourless solution, having an exceedingly pungent, characteristic odour
A.Positive tests for ammonia
Non-volatile matterNot more than 0,02 %
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
Chemical nameMagnesium hydroxide
EINECS215-170-3
Chemical formulaMgOH2
Molecular weight58,32
AssayContent not less than 95,0 % on the anhydrous basis
DescriptionOdourless, white bulky powder
A.Positive test for magnesium and for alkali
B.SolubilityPractically insoluble in water and in ethanol
Loss on dryingNot more than 2,0 % (105 °C, 2h)
Loss on ignitionNot more than 33 % (800 °C to constant weight)
Calcium oxideNot more than 1,5 %
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
SynonymsBurnt lime
Chemical nameCalcium oxide
EINECS215-138-9
Chemical formulaCaO
Molecular weight56,08
AssayContent not less than 95,0 % on the ignited basis
DescriptionOdourless, hard, white or greyish white masses of granules, or white to greyish powder
A.Positive test for alkali and for calciumB.Heat is generated on moistening the sample with water
C.SolubilitySlightly soluble in water. Insoluble in ethanol. Soluble in glycerol
Loss on ignitionNot more than 10,0 % (ca 800 °C to constant weight)
Acid insoluble matterNot more than 1,0 %
BariumNot more than 300 mg/kg
Magnesium and alkali saltsNot more than 1,5 %
FluorideNot more than 50 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
Chemical nameMagnesium oxide
EINECS215-171-9
Chemical formulaMgO
Molecular weight40,31
AssayContent not less than 98,0 % on the ignited basis
DescriptionA very bulky, white powder known as light magnesium oxide or a relative dense, white powder known as heavy magnesium oxide. 5 g of light magnesium oxide occupy a volume of 40 to 50 ml, while 5 g of heavy magnesium oxide occupy a volume of 10 to 20 ml
A.Positive test for alkali and for magnesium
B.SolubilityPractically insoluble in water. Insoluble in ethanol
Loss on ignitionNot more than 5,0 % (ca 800 °C to constant weight)
Calcium oxideNot more than 1,5 %
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
SynonymsYellow prussiate of soda, sodium hexacyanoferrate
Chemical nameSodium ferrocyanide
EINECS237-081-9
Chemical formulaNa4FeCN6 · 10 H2O
Molecular weight484,1
AssayContent not less than 99,0 %
DescriptionYellow crystals or crystalline powder
A.Positive test for sodium and for ferrocyanide
Free moistureNot more than 1,0 %
Water insoluble matterNot more than 0,03 %
ChlorideNot more than 0,2 %
SulphateNot more than 0,1 %
Free cyanideNot detectable
FerricyanideNot detectable
LeadNot more than 5 mg/kg
SynonymsYellow prussiate of potash, potassium hexacyanoferrate
Chemical namePotassium ferrocyanide
EINECS237-722-2
Chemical formulaK4FeCN6 · 3 H2O
Molecular weight422,4
AssayContent not less than 99,0 %
DescriptionLemon yellow crystals
A.Positive test for potassium and for ferrocyanide
Free moistureNot more than 1,0 %
Water insoluble matterNot more than 0,03 %
ChlorideNot more than 0,2 %
SulphateNot more than 0,1 %
Free cyanideNot detectable
FerricyanideNot detectable
LeadNot more than 5 mg/kg
SynonymsYellow prussiate of lime, calcium hexacyanoferrate
Chemical nameCalcium ferrocyanide
EINECS215-476-7
Chemical formulaCa2FeCN6 · 12H2O
Molecular weight508,3
AssayContent not less than 99,0 %
DescriptionYellow crystals or crystalline powder
A.Positive test for calcium and for ferrocyanide
Free moistureNot more than 1,0 %
Water insoluble matterNot more than 0,03 %
ChlorideNot more than 0,2 %
SulphateNot more than 0,1 %
Free cyanideNot detectable
FerricyanideNot detectable
LeadNot more than 5 mg/kg
SynonymsSALP
Chemical nameSodium trialuminium tetradecahydrogen octaphosphate tetrahydrate (A) orTrisodium dialuminium pentadecahydrogen octaphosphate (B)
EINECS232-090-4
Chemical formulaNaAl3H14PO48 · 4H2O (A)Na3Al2H15PO48 (B)
Molecular weight949,88 (A)897,82 (B)
AssayContent not less than 95,0 % (both forms)
DescriptionWhite odourless powder
A.Positive test for sodium, for aluminium and for phosphate
B.pHAcid to litmus
C.SolubilityInsoluble in water. Soluble in hydrochloric acid
Loss on ignition19,5 % - 21,0 % (A) } (750 °C - 800 °C, 2h)15 % - 16 % (B) } (750 °C - 800 °C, 2h)
FluorideNot more than 25 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 4 mg/kg
CadmiumNot more than 1 mg/kg
MercuryNot more than 1 mg/kg
SynonymsSilica, silicium dioxide
DefinitionSilicon dioxide is an amorphous substance, which is produced synthetically by either a vapour-phase hydrolysis process, yielding fumed silica, or by a wet process, yielding precipitated silica, silica gel, or hydrous silica. Fumed silica is produced in essentially an anhydrous state, whereas the wet-process products are obtained as hydrates or contain surface absorbed water
Chemical nameSilicon dioxide
EINECS231-545-4
Chemical formulaSiO2n
Molecular weight60,08 (SiO2)
AssayContent after ignition not less than 99,0 % (fumed silica) or 94,0 % (hydrated forms)
DescriptionWhite, fluffy powder or granulesHygroscopic
A.Positive test for silica
Loss on dryingNot more than 2,5 % (fumed silica, 105 °C, 2h)Not more than 8,0 % (precipitated silica and silica gel, 105 °C, 2h)Not more than 70 % (hydrous silica, 105 °C, 2h)
Loss on ignitionNot more than 2,5 % after drying (1000 °C, fumed silica)Not more than 8,5 % after drying (1000 °C, hydrated forms)
Soluble ionisable saltsNot more than 5,0 % (asNa2SO4)
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
DefinitionCalcium silicate is a hydrous or anhydrous silicate with varying proportions of CaO andSiO2
Chemical nameCalcium silicate
EINECS215-710-8
AssayContent on the anhydrous basis:asSiO2 not less than 50 % and not more than 95 %as CaO not less than 3 % and not more than 35 %
DescriptionWhite to off-white free-flowing powder that remains so after absorbing relatively large amounts of water or other liquids
A.Positive test for silicate and for calcium
B.Forms a gel with mineral acids
Loss on dryingNot more than 10 % (105 °C, 2h)
Loss on ignitionNot less than 5 % and not more than 14 % (1000 °C, constant weight)
SodiumNot more than 3 %
FluorideNot more than 50 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
DefinitionMagnesium silicate is a synthetic compound of which the molar ratio of magnesium oxide to silicon dioxide is approximately 2:5
AssayContent not less than 15 % of MgO and not less than 67 % ofSiO2 on the ignited basis
DescriptionVery fine, white, odourless powder, free from grittiness
A.Positive test for magnesium and for silicate
B.pH of a 10 % slurryBetween 7,0 and 10,8
Loss on dryingNot more than 15 % (105 °C, 2h)
Loss on ignitionNot more than 15 % after drying (1000 °C, 20 min)
Water soluble saltsNot more than 3 %
Free alkaliNot more than 1 % (as NaOH)
FluorideNot more than 10 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Chemical nameMagnesium trisilicate
Chemical formulaMg2Si3O8 · xH2O (approximate composition)
EINECS239-076-7
AssayContent not less than 29,0 % of MgO and not less than 65,0 % ofSiO2 both on the ignited basis
DescriptionFine, white powder, free from grittiness
A.Positive test for magnesium and for silicate
B.pH of a 5 % slurryBetween 6,3 and 9,5
Loss on ignitionNot less than 17 % and not more than 34 % (1000 °C)
Water soluble saltsNot more than 2 %
Free alkaliNot more than 1 % (as NaOH)
FluorideNot more than 10 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
DefinitionLinear fatty acids, caprylic acid (C8), capric acid (C10), laurinc acid (C12), myristic acid (C14), palmitic acid (C16), stearic acid (C18), oleic acid (C18:1)
Chemical nameoctanoic acid (C8), decanoic acid (C10), dodecanoic acid (C12), tetradecanoic acid (C14), hexadecanoic acid (C16), octadecanoic acid (C18), 9-octadecenoic acid (C18:1)
AssayNot less than 98 % by chromatography
DescriptionA colourless liquid or white solid obtained from oils and fats
A.Individual fatty acids can be identified by acid value, iodine value, gas chromatography and molecular weight
Residue on ignitionNot more than 0,1 %
Unsaponifiable matterNot more than 1,5 %
WaterNot more than 0,2 % (Karl Fischer method)
ArsenicNot more than 3 mg/kg
LeadNot more than 1 mg/kg
MercuryNot more than 1 mg/kg
SynonymsD-gluconic acid, dextronic acid
DefinitionGluconic acid is an aqueous solution of gluconic acid and glucono-delta-lactone
Chemical nameGluconic acid
Chemical formulaC6H12O7 (gluconic acid)
Molecular weight196,2
AssayContent not less than 50,0 % (as gluconic acid)
DescriptionColourless to light yellow, clear syrupy liquid
A.Formation of phenylhydrazine derivative positiveCompound formed melts between 196 °C and 202 °C with decomposition
Residue on ignitionNot more than 1,0 %
Reducing matterNot more than 0,75 % (as D-glucose)
ChlorideNot more than 350 mg/kg
SulphateNot more than 240 mg/kg
SulphiteNot more than 20 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
SynonymsGluconolactone, GDL, D-gluconic acid delta-lactone, delta-gluconolactone
DefinitionGlucono-delta-lactone is the cyclic 1,5-intramolecular ester of D-gluconic acid. In aqueous media it is hydrolysed to an equilibrium mixture of D-gluconic acid (55 %-66 %) and the delta- and gamma-lactones
Chemical nameD-Glucono-1,5-lactone
EINECS202-016-5
Chemical formulaC6H10O6
Molecular weight178,14
AssayContent not less than 99,0 % on the anhydrous basis
DescriptionFine, white, nearly odourless, crystalline powder
A.Formation of phenylhydrazine derivative of gluconic acid positiveCompound formed melts between 196 °C and 202 °C with decomposition
B.SolubilityFreely soluble in water. Sparingly soluble in ethanol
C.Melting point152 °C ± 2 °C
WaterNot more than 1,0 % (Karl Fischer method)
Reducing substancesNot more than 0,75 % (as D-glucose)
LeadNot more than 2 mg/kg
SynonymsSodium salt of D-gluconic acid
Chemical nameSodium D-gluconate
EINECS208-407-7
Chemical formulaC6H11NaO7 (anhydrous)
Molecular weight218,14
AssayContent not less than 98,0 %
DescriptionWhite to tan, granular to fine, crystalline powder
A.Positive test for sodium and for gluconate
B.SolubilityVery soluble in water. Sparingly soluble in ethanol
C.pH of a 10 % solutionBetween 6,5 and 7,5
Reducing matterNot more than 1,0 % (as D-glucose)
LeadNot more than 2 mg/kg
SynonymsPotassium salt of D-gluconic acid
Chemical namePotassium D-gluconate
EINECS206-074-2
Chemical formulaC6H11KO7 (anhydrous)C6H11KO7 · H2O (monohydrate)
Molecular weight234,25 (anhydrous)252,26 (monohydrate)
AssayContent not less than 97,0 % and not more than 103,0 % on dried basis
DescriptionOdourless, free flowing white to yellowish white, crystalline powder or granules
A.Positive test for potassium and for gluconate
B.pH of a 10 % solutionBetween 7,0 and 8,3
Loss on dryingAnhydrous: not more than 3,0 % (105 °C, 4h, vacuum)Monohydrate: not less than 6 % and not more than 7,5 % (105 °C, 4h, vacuum)
Reducing substancesNot more than 1,0 % (as D-glucose)
LeadNot more than 2 mg/kg
SynonymsCalcium salt of D-gluconic acid
Chemical nameCalcium di-D-gluconate
EINECS206-075-8
Chemical formulaC12H22CaO14 (anhydrous)C12H22CaO14 · H2O (monohydrate)
Molecular weight430,38 (anhydrous form)448,39 (monohydrate)
AssayContent not less than 98,0 % and not more than 102 % on the anhydrous and monohydrate basis
DescriptionOdourless, white crystalline granules or powder, stable in air
A.Positive test for calcium and for gluconate
B.SolubilitySoluble in water, insoluble in ethanol
C.pH of a 5 % solutionBetween 6,0 and 8,0
Loss on dryingNot more than 3,0 % (105 °C, 16h) (anhydrous)Not more than 2,0 % (105 °C, 16h) (monohydrate)
Reducing substancesNot more than 1,0 % (as D-glucose)
LeadNot more than 2 mg/kg
Synonyms (gly)Aminoacetic acid, glycocoll
(Na salt)Sodium glycinate
Chemical name (gly)Aminoacetic acid
(Na salt)Sodium glycinate
Chemical formula (gly)C2H5NO2
(Na salt)C2H5NO2 Na
EINECS (gly)200-272-2
(Na salt)227-842-3
Molecular weight (gly)75,07
(Na salt)98
AssayContent not less than 98,5 % on the anhydrous basis
DescriptionWhite crystals or crystalline powder
A.Positive test for aminoacid (gly and Na salt)
B.Positive test for sodium (Na salt)
Loss on drying (gly)Not more than 0,2 % (105 °C, 3h)
(Na salt)Not more than 0,2 % (105 °C, 3h)
Residue on ignition (gly)Not more than 0,1 %
(Na salt)Not more than 0,1 %
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
SynonymsPolydimethyl siloxane, silicone fluid, silicone oil, dimethyl silicone
DefinitionDimethylpolysiloxane is a mixture of fully methylated linear siloxane polymers containing repeating units of the formulaCH32 SiO and stablised with trimethylsiloxy end-blocking units of the formulaCH33 SiO
Chemical nameSiloxanes and silicones, di-methyl
Chemical formulaCH33-Si-O-SiCH32n-O-SiCH33
AssayContent of total silicon not less than 37,3 % and not more than 38,5 %
DescriptionClear, colourless, viscous liquid
A.Specific gravity (25°/25 °C)Between 0,964 and 0,977
B.Refractive indexnD25Between 1,400 and 1,405
C.Infrared spectrum characteristic of the compound
Loss on dryingNot more than 0,5 % (150 °C, 4h)
ViscosityNot less than 1,00 · 10-4 m2s-1 at 25 °C
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
SynonymsWhite wax, yellow wax
DefinitionYellow bees wax is the wax obtained by melting the walls of the honeycomb made by the honey bee, Apis mellifera L., with hot water and removing foreign matterWhite beeswax is obtained by bleaching yellow beeswax
EINECS232-383-7 (beeswax)
DescriptionYellowish white (white form) or yellowish to greyish brown (yellow form) pieces or plates with a fine-grained and non-crystalline fracture, having an agreeable, honey-like odour
A.Melting rangeBetween 62 °C and 65 °C
B.Specific gravityAbout 0,96
C.SolubilityInsoluble in waterSparingly soluble in alcoholVery soluble in chloroform and ether
Acid valueNot less than 17 and not more than 24
Saponification value87-104
Peroxide valueNot more than 5
Glycerol and other polyolsNot more than 0,5 % (as glycerol)
Ceresin, paraffins and certain other waxesAbsent
Fats, Japan wax, rosin and soapsAbsent
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
DefinitionCandelilla wax is a purified wax obtained from the leaves of the candelilla plant, Euphorbia antisyphilitica
EINECS232-347-0
DescriptionHard, yellowish brown, opaque to translucent wax
A.Specific gravityAbout 0,983
B.Melting rangeBetween 68,5 °C and 72,5 °C
C.SolubilityInsoluble in waterSoluble in chloroform and toluene
Acid valueNot less than 12 and not more than 22
Saponification valueNot less than 43 and not more than 65
Glycerol and other polyolsNot more than 0,5 % (as glycerol)
Ceresin, paraffins and certain other waxesAbsent
Fats, Japan wax, rosin and soapsAbsent
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
DefinitionCarnauba wax is a purified wax obtained from the leaf buds and leaves of the Brazilian Mart wax palm, Copernicia cereferia
EINECS232-399-4
DescriptionLight brown to pale yellow powder or flakes or hard and brittle solid with a resinous fracture
A.Specific gravityAbout 0,997
B.Melting rangeBetween 82 °C and 86 °C
C.SolubilityInsoluble in waterPartly soluble in boiling ethanolSoluble in chloroform and diethyl ether
Sulphated ashNot more than 0,25 %
Acid valueNot less than 2 and not more than 7
Ester valueNot less than 71 and not more than 88
Unsaponifiable matterNot less than 50 % and not more than 55 %
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
SynonymsBleached shellac, white shellac
DefinitionShellac is the purified and bleached lac, the resinous secretion of the insect Laccifer (Tachardia) lacca Kerr (Fam. Coccidae)
EINECS232-549-9
DescriptionBleached shellac — off-white, amorphous, granular resinWax-free bleached shellac — light yellow, amorphous, granular resin
A.SolubilityInsoluble in water; freely (though very slowly) soluble in alcohol; slightly soluble in acetone
B.Acid valueBetween 60 and 89
Loss on dryingNot more than 6,0 % (40 °C, over silica gel, 15h)
RosinAbsent
WaxBleached shellac: not more than 5,5 %Wax-free bleached shellac: not more than 0,2 %
LeadNot more than 2 mg/kg
DefinitionL-cysteine hydrochloride or hydrochloride monohydrate. Human hair may not be used as a source for this substance
EINECS200-157-7 (anhydrous)
Chemical formulaC3H7NO2S · HCl · n H20 (where n = 0 or 1)
Molecular weight157,62 (anhydrous)
AssayContent not less than 98,0 % and not more than 101,5 % on the anhydrous basis
DescriptionWhite powder or colourless crystals
A.SolubilityFreely soluble in water and in ethanol
B.Melting rangeAnhydrous form melts at about 175 °C
C.Specific rotationα20D: between + 5,0° and + 8,0° orα25D: between + 4,9° and 7,9°
Loss on dryingBetween 8,0 % and 12,0 %Not more than 2,0 % (anhydrous form)
Residue on ignitionNot more than 0,1 %
Ammonium-ionNot more than 200 mg/kg
ArsenicNot more than 1,5 mg/kg
LeadNot more than 5 mg/kg
SynonymsUrea
EINECS200-315-5
Chemical formulaCH4N2O
Molecular weight60,06
AssayContent not less than 99,0 % on the anhydrous basis
DescriptionColourless to white, prismatic, crystalline powder or small, white pellets
A.SolubilityVery soluble in waterSoluble in ethanol
B.Precipitation with nitric acidTo pass the test a white, crystalline precipitate is formed
C.Colour reactionTo pass the test a reddish-violet colour is produced
D.Melting range132 °C to 135 °C
Loss on dryingNot more than 1,0 % (105 °C, 1h)
Sulphated ashNot more than 0,1 %
Ethanol-insoluble matterNot more than 0,04 %
AlkalinityPasses test
Ammonium-ionNot more than 500 mg/kg
BiuretNot more than 0,1 %
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
Chemical nameArgon
EINECS231-147-0
Chemical formulaAr
Molecular weight40
AssayNot less than 99 %
DescriptionColourless, odourless, non-flammable gas
WaterNot more than 0,05 %
Methane and other hydrocarbons calculated as methaneNot more than 100 μl/l
Chemical nameHelium
EINECS231-168-5
Chemical formulaHe
Molecular weight4
AssayNot less than 99 %
DescriptionColourless, odourless, non-flammable gas
WaterNot more than 0,05 %
Methane and other hydrocarbons calculated as methaneNot more than 100 μl/l
Chemical nameNitrogen
EINECS231-783-9
Chemical formulaN2
Molecular weight28
AssayNot less than 99 %
DescriptionColourless, odourless, non-flammable gas
WaterNot more than 0,05 %
Carbon monoxideNot more than 10 μl/l
Methane and other hydrocarbons calculated as methaneNot more than 100 μl/l
Nitrogen dioxide and nitrogen oxideNot more than 10 μl/l
OxygenNot more than 1 %
Chemical nameNitrous oxide
EINECS233-032-0
Chemical formulaN2O
Molecular weight44
AssayNot less than 99 %
DescriptionColourless, non-flammable gas, sweetish odour
WaterNot more than 0,05 %
Carbon monoxideNot more than 30 μl/l
Nitrogen dioxide and nitrogen oxideNot more than 10 μl/l
Chemical nameOxygen
EINECS231-956-9
Chemical formulaO2
Molecular weight32
AssayNot less than 99 %
DescriptionColourless, odourless, non-flammable gas
WaterNot more than 0,05 %
Methane and other hydrocarbons calculated as methaneNot more than 100 μl/l
SynonymsSoapbark extract, Quillay bark extract, Panama bark extract, Quillai extract, Murillo bark extract, China bark extract
DefinitionQuillaia extract is obtained by aqueous extraction of Quillai saponaria Molina, or other Quillaia species, trees of the family Rosaceae. It contains a number of triterpenoid saponins consisting of glycosides of quillaic acid. Some sugars including glucose, galactose, arabinose, xylose, and rhamnose are also present, along with tannin, calcium oxalate and other minor components
DescriptionQuillaia extract in the powder form is light brown with a pink tinge. It is also available as an aqueous solution
A.pH of a 2,5 % solutionBetween 4,5 and 5,5
WaterNot more than 6,0 % (Karl Fischer method) (powder form only)
ArsenicNot more than 2 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
DefinitionInvertase is produced from Saccharomyces cerevisiae
Systematic nameβ-D-Fructofuranoside fructohydrolase
Enzyme Commission NoEC 3.2.1.26
EINECS232-615-7
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
CadmiumNot more than 0,5 mg/kg
Total bacterial countNot more than 50000/g
Salmonella spp.Absent by test in 25 g
ColiformsNot more than 30/g
E. coliAbsent by test in 25 g
SynonymsModified polydextroses
DefinitionRandomly bonded glucose polymers with some sorbitol end-groups, and with citric acid or phosphoric acid residues attached to the polymers by mono or diester bonds. They are obtained by melting and condensation of the ingredients and consist of approximately 90 parts D-glucose, 10 parts sorbitol and 1 part citric acid or 0,1 part phosphoric acid. The 1,6-glucosidic linkage predominates in the polymers but other linkages are present. The products contain small quantities of free glucose, sorbitol, levoglucosan (1,6-anhydro-D-glucose) and citric acid and may be neutralised with any food grade base and/or decolorised and deionised for further purification. The products may also be partially hydrogenated with Raney nickel catalyst to reduce residual glucose. Polydextrose-N is neutralised polydextrose
AssayContent not less than 90 % of polymer on the ash free and anhydrous basis
DescriptionWhite to light tan-coloured solid. Polydextroses dissolve in water to give a clear, colourless to straw coloured solution
A.Positive tests for sugar and for reducing sugar
B.pH of a 10 % solutionBetween 2,5 and 7,0 for polydextroseBetween 5,0 and 6,0 for polydextrose-N
WaterNot more than 4,0 % (Karl Fischer method)
Sulphated ashNot more than 0,3 % (polydextrose)Not more than 2,0 % (polydextrose N)
NickelNot more than 2 mg/kg for hydrogenated polydextroses
1,6-Anhydro-D-glucoseNot more than 4,0 % on the ash-free and the dried basis
Glucose and sorbitolNot more than 6,0 % combined on the ash-free and the dried basis; glucose and sorbitol are determined separately
Molecular weight limitNegative test for polymers of molecular weight greater than 22,000
5-HydroxymethylfurfuralNot more than 0,1 % (polydextrose)Not more than 0,05 % (polydextrose-N)
LeadNot more than 0,5 mg/kg
DefinitionOxidised starch is starch treated with sodium hypochlorite
DescriptionWhite or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
A.If not pregelatinised: by microscopic observationB.Iodine staining positive (dark blue to light red colour)
Loss on dryingNot more than 15,0 % for cereal starchNot more than 21,0 % for potato starchNot more than 18,0 % for other starches
Carboxyl groupsNot more than 1,1 %
Sulphur dioxideNot more than 50 mg/kg for modified cereal starchesNot more than 10 mg/kg for other modified starches, unless otherwise specified
ArsenicNot more than 1 mg/kg
LeadNot more than 2 mg/kg
MercuryNot more than 0,1 mg/kg
DefinitionMonostarch phosphate is starch esterified with ortho-phosphoric acid, or sodium or potassium ortho-phosphate or sodium tripolyphosphate
DescriptionWhite or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
A.If not pregelatinised: by microscopic observationB.Iodine staining positive (dark blue to light red colour)
Loss on dryingNot more than 15,0 % for cereal starchNot more than 21,0 % for potato starchNot more than 18,0 % for other starches
Residual phosphateNot more than 0,5 % (as P) for wheat or potato starchNot more than 0,4 % (as P) for other starches
Sulphur dioxideNot more than 50 mg/kg for modified cereal starchesNot more than 10 mg/kg for other modified starches, unless otherwise specified
ArsenicNot more than 1 mg/kg
LeadNot more than 2 mg/kg
MercuryNot more than 0,1 mg/kg
DefinitionDistarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychloride
DescriptionWhite or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
A.If not pregelatinised: by microscopic observationB.Iodine staining positive (dark blue to light red colour)
Loss on dryingNot more than 15,0 % for cereal starchNot more than 21,0 % for potato starchNot more than 18,0 % for other starches
Residual phosphateNot more than 0,5 % (as P) for wheat or potato starchNot more than 0,4 % (as P) for other starches
Sulphur dioxideNot more than 50 mg/kg for modified cereal starchesNot more than 10 mg/kg for other modified starches, unless otherwise specified
ArsenicNot more than 1 mg/kg
LeadNot more than 2 mg/kg
MercuryNot more than 0,1 mg/kg
DefinitionPhosphated distarch phosphate is starch having undergone a combination of treatments as described for monostarch phosphate and for distarch phosphate
DescriptionWhite or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
A.If not pregelatinised: by microscopic observationB.Iodine staining positive (dark blue to light red colour)
Loss on dryingNot more than 15,0 % for cereal starchNot more than 21,0 % for potato starchNot more than 18,0 % for other starches
Residual phosphateNot more than 0,5 % (as P) for wheat or potato starchNot more than 0,4 % (as P) for other starches
Sulphur dioxideNot more than 50 mg/kg for modified cereal starchesNot more than 10 mg/kg for other modified starches, unless otherwise specified
ArsenicNot more than 1 mg/kg
LeadNot more than 2 mg/kg
MercuryNot more than 0,1 mg/kg
DefinitionAcetylated distarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychloride and esterified by acetic anhydride or vinyl acetate
DescriptionWhite or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
A.If not pregelatinised: by microscopic observationB.Iodine staining positive (dark blue to light red colour)
Loss on dryingNot more than 15,0 % for cereal starchNot more than 21,0 % for potato starchNot more than 18,0 % for other starches
Acetyl groupsNot more than 2,5 %
Residual phosphateNot more than 0,14 % (as P) for wheat or potato starchNot more than 0,04 % (as P) for other starches
Vinyl acetateNot more than 0,1 mg/kg
Sulphur dioxideNot more than 50 mg/kg for modified cereal starchesNot more than 10 mg/kg for other modified starches, unless otherwise specified
ArsenicNot more than 1 mg/kg
LeadNot more than 2 mg/kg
MercuryNot more than 0,1 mg/kg
SynonymsStarch acetate
DefinitionAcetylated starch is starch esterified with acetic anhydride or vinyl acetate
DescriptionWhite or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
A.If not pregelatinised: by microscopic observationB.Iodine staining positive (dark blue to light red colour)
Loss on dryingNot more than 15,0 % for cereal starchNot more than 21,0 % for potato starchNot more than 18,0 % for other starches
Acetyl groupsNot more than 2,5 %
Vinyl acetateNot more than 0,1 mg/kg
Sulphur dioxideNot more than 50 mg/kg for modified cereal starchesNot more than 10 mg/kg for other modified starches, unless otherwise specified
ArsenicNot more than 1 mg/kg
LeadNot more than 2 mg/kg
MercuryNot more than 0,1 mg/kg
DefinitionAcetylated distarch adipate is starch cross-linked with adipic anhydride and esterified with acetic anhydride
DescriptionWhite or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
A.If not pregelatinised: by microscopic observationB.Iodine staining positive (dark blue to light red colour)
Loss on dryingNot more than 15,0 % for cereal starchNot more than 21,0 % for potato starchNot more than 18,0 % for other starches
Acetyl groupsNot more than 2,5 %
Adipate groupsNot more than 0,135 %
Sulphur dioxideNot more than 50 mg/kg for modified cereal starchesNot more than 10 mg/kg for other modified starches, unless otherwise specified
ArsenicNot more than 1 mg/kg
LeadNot more than 2 mg/kg
MercuryNot more than 0,1 mg/kg
DefinitionHydroxypropyl starch is starch etherified with propylene oxide
DescriptionWhite or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
A.If not pregelatinised: by microscopic observationB.Iodine staining positive (dark blue to light red colour)
Loss on dryingNot more than 15,0 % for cereal starchNot more than 21,0 % for potato starchNot more than 18,0 % for other starches
Hydroxypropyl groupsNot more than 7,0 %
Propylene chlorohydrinNot more than 1 mg/kg
Sulphur dioxideNot more than 50 mg/kg for modified cereal starchesNot more than 10 mg/kg for other modified starches, unless otherwise specified
ArsenicNot more than 1 mg/kg
LeadNot more than 2 mg/kg
MercuryNot more than 0,1 mg/kg
DefinitionHydroxypropyl distarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychloride and etherified with propylene oxide
DescriptionWhite or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
A.If not pregelatinised: by microscopic observationB.Iodine staining positive (dark blue to light red colour)
Loss on dryingNot more than 15,0 % for cereal starchNot more than 21,0 % for potato starchNot more than 18,0 % for other starches
Hydroxypropyl groupsNot more than 7,0 %
Residual phosphateNot more than 0,14 % (as P) for wheat or potato starchNot more than 0,04 (as P) for other starches
Propylene chlorohydrinNot more than 1 mg/kg
Sulphur dioxideNot more than 50 mg/kg for modified cereal starchesNot more than 10 mg/kg for other modified starches, unless otherwise specified
ArsenicNot more than 1 mg/kg
LeadNot more than 2 mg/kg
MercuryNot more than 0,1 mg/kg
SynonymsSSOS
DefinitionStarch sodium octenyl succinate is starch esterified with octenylsuccinic anhydride
DescriptionWhite or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
A.If not pregelatinised: by microscopic observationB.Iodine staining positive (dark blue to light red colour)
Loss on dryingNot more than 15,0 % for cereal starchNot more than 21,0 % for potato starchNot more than 18,0 % for other starches
Octenylsuccinyl groupsNot more than 3 %
Octenylsuccinic acid residueNot more than 0,3 %
Sulphur dioxideNot more than 50 mg/kg for modified cereal starchesNot more than 10 mg/kg for other modified starches, unless otherwise specified
ArsenicNot more than 1 mg/kg
LeadNot more than 2 mg/kg
MercuryNot more than 0,1 mg/kg
DefinitionAcetylated oxidised starch is starch treated with sodium hypochlorite followed by esterification with acetic anhydride
DescriptionWhite or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
A.If not pregelatinised: by microscopic observationB.Iodine staining positive (dark blue to light red colour)
Loss on dryingNot more than 15,0 % for cereal starchNot more than 21,0 % for potato starchNot more than 18,0 % for other starches
Carboxyl groupsNot more than 1,3 %
Acetyl groupsNot more than 2,5 %
Sulphur dioxideNot more than 50 mg/kg for modified cereal starchesNot more than 10 mg/kg for other modified starches, unless otherwise specified
ArsenicNot more than 1 mg/kg
LeadNot more than 2 mg/kg
MercuryNot more than 0,1 mg/kg
SynonymsEthyl citrate
Chemical nameTriethyl-2-hydroxypropan-1,2,3-tricarboxylate
EINECS201-070-7
Chemical formulaC12H20O7
Molecular weight276,29
AssayContent not less than 99,0 %
DescriptionOdourless, practically colourless, oily liquid
A.Specific gravityd2525: 1,135-1,139
B.Refractive indexnD20: 1,439-1,441
WaterNot more than 0,25 % (Karl Fischer method)
AcidityNot more than 0,02 % (as citric acid)
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
SynonymsTriacetin
Chemical nameGlyceryl triacetate
EINECS203-051-9
Chemical formulaC9H14O6
Molecular weight218,21
AssayContent not less than 98,0 %
DescriptionColourless, somewhat oily liquid having a slightly fatty odour
A.Positive tests for acetate and for glycerol
B.Refractive indexBetween 1,429 and 1,431 at 25 °C
C.Specific gravity (25 °C/25 °C)Between 1,154 and 1,158
D.Boiling rangeBetween 258° and 270 °C
WaterNot more than 0,2 % (Karl Fischer method)
Sulphated ashNot more than 0,02 % (as citric acid)
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
SynonymsPropylene glycol
Chemical names1,2-dihydroxypropane
EINECS200-338-0
Chemical formulaC3H8O2
Molecular weight76,10
AssayContent not less than 99,5 % on the anhydrous basis
DescriptionClear, colourless, hygroscopic, viscous liquid
A.SolubilitySoluble in water, ethanol and acetone
B.Specific gravityd2020: 1,035-1,040
C.Refractive indexn20D: 1,431-1,433
Distillation range99 % v/v distils between 185 °C-189 °C
Sulphated ashNot more than 0,07 %
WaterNot more than 1,0 % (Karl Fischer method)
LeadNot more than 5 mg/kg
E 170 (i) CALCIUM CARBONATEPurity criteria for this additive are the same as set out for this additive in the Annex to Directive 95/45/EC laying down specific purity criteria concerning colours for use in foodstuffsOJ L 226, 22.9.1995, p. 13..E 353 METATARTARIC ACID
DefinitionIdentificationPurity
SynonymsDitartaric acid
Chemical nameMetatartaric acid
Chemical formulaC4H6O6
AssayNot less than 99,5 %
DescriptionCrystalline or powder form with a white or yellowish colour. Very deliquescent with a faint odour of caramel
A.Very soluble in water and ethanol.
B.Place a sample of 1 to 10 mg of this substance in a test tube with 2 ml of concentrated sulfuric acid and 2 drops of sulpho-resorcinol reagent. When heated to 150 °C, an intense violet coloration appears
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
E 354 CALCIUM TARTRATE
DefinitionIdentificationPurity
SynonymsL-Calcium tartrate
Chemical nameCalcium L(+)-2,3-dihydroxybutanedioate di-hydrate
Chemical formulaC4H4CaO6 · 2H2O
Molecular weight224,18
AssayNot less than 98,0 %
DescriptionFine crystalline powder with a white or off-white colour
A.Slightly soluble in water. Solubility approximately 0,01 g/100 ml water (20 °C). Sparingly soluble in ethanol. Slightly soluble in diethyl ether. Soluble in acids
B.Specific rotation [α]20D+7,0° to +7,4° (0,1 % in a 1N de HCl solution)
C.pH of a 5 % slurryBetween 6,0 and 9,0
Sulphates (as H2SO4)Not more than 1 g/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
E 356 SODIUM ADIPATE
DefinitionIdentificationPurity
Chemical nameSodium adipate
EINECS231-293-5
Chemical formulaC6H8Na2O4
Molecular weight190,11
AssayContent not less than 99,0 % (on anhydrous basis)
DescriptionWhite odourless crystals or crystalline powder
A.Melting range151 °C-152 °C (for adipic acid)
B.SolubilityApproximately 50 g/100 ml water (20 °C)
C.Positive test for sodium
WaterNot more than 3 % (Karl Fischer)
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
E 357 POTASSIUM ADIPATE
DefinitionIdentificationPurity
Chemical namePotassium adipate
EINECS242-838-1
Chemical formulaC6H8K2O4
Molecular weight222,32
AssayContent not less than 99,0 % (on anhydrous basis)
DescriptionWhite odourless crystals or crystalline powder
A.Melting range151 °C-152 °C (for adipic acid)
B.SolubilityApproximately 60 g/100 ml water (20 °C)
C.Positive test for potassium
WaterNot more than 3 % (Karl Fischer)
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
E 420(i) SORBITOLPurity criteria for this additive are the same as set out for this additive in the Annex to Directive 95/31/EC laying down specific criteria of purity concerning sweeteners for use in foodstuffsOJ L 178, 28.7.1995, p. 1..E 420(ii) SORBITOL SYRUPPurity criteria for this additive are the same as set out for this additive in the Annex to Directive 95/31/EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs.E 421 MANNITOLPurity criteria for this additive are the same as set out for this additive in the Annex to Directive 95/31/EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs.E 425(i) KONJAC GUM
IdentificationPurity
DefinitionKonjac gum is a water-soluble hydrocolloid obtained from the Konjac flour by aqueous extraction. Konjac flour is the unpurified raw product from the root of the perennial plant Amorphophallus konjac The main component of Konjac gum is the water-soluble high-molecular-weight polysaccharide glucomannan, which consists of D-mannose and D-glucose units at a molar ration of 1,6:1,0, connected by β(1-4)-glycosidic bonds. Shorter side chains are attached through β(1-3)-glycosidic bonds, and acetyl groups occur at random at a ratio of about 1 group per 9 to 19 sugar units
Molecular weightThe main component, glucomannan, has an average molecular weight of 200000 to 2000000
AssayNot less than 75 % carbohydrate
DescriptionA white to cream to light tan powder
A.SolubilityDispersible in hot or cold water forming a highly viscous solution with a pH between 4,0 and 7,0
B.Gel formationAdd 5 ml of a 4 % sodium borate solution to a 1 % solution of the sample in a test tube, and shake vigorously. A gel forms
C.Formation of heat-stable gelPrepare a 2 % solution of the sample by heating it in a boiling water bath for 30 min, with continuous agitation and then cooling the solution to room temperature. For each g of the sample used to prepare 30 g of the 2 % solution, add 1 ml of 10 % potassium carbonate solution to the fully hydrated sample at ambient temperature. Heat the mixture in a water bath to 85 °C, and maintain for 2 h without agitation. Under these conditions a thermally stable gel is formed
D.Viscosity (1 % solution)Not less than 3 kgm-1s-1 at 25 °C
Loss on dryingNot more than 12 % (105 °C, 5 h)
StarchNot more than 3 %
ProteinNot more than 3 % (N × 5,7)Determine nitrogen by Kjeldahl method. The percentage of nitrogen in the sample multiplied by 5,7 gives the percent of protein in the sample
Ether-soluble materialNot more than 0,1 %
Total ashNot more than 5,0 % (800 °C, 3 to 4h)
ArsenicNot more than 3 mg/kg
LeadNot more than 2 mg/kg
Salmonella spp.Absent in 12,5 g
E. coliAbsent in 5 g
E 425(ii) KONJAC GLUCOMANNAN
IdentificationPurity
DefinitionKonjac glucomannan is a water-soluble hydrocolloid obtained from Konjac flour by washing with water-containing ethanol. Konjac flour is the unpurified raw product from the tuber of the perennial plant Amorphophallus konjac. The main component is the water-soluble high-molecular-weight polysaccharide glucomannan, which consists of D-mannose and D-glucose units at a molar ration of 1,6:1,0, connected by β(1-4)-glycosidic bonds with a branch at about each 50th or 60th unit. About each 19th sugar residue is acetylated
Molecular weight500000 to 2000000
AssayTotal dietary fibre: not less than 95 % on a dry weight basis
DescriptionWhite to slightly brownish fine particle size, free flowing and odourless powder
A.SolubilityDispersible in hot or cold water forming a highly viscous solution with a pH between 5,0 and 7,0. Solubility is increased by heat and mechanical agitation
B.Formation of heat-stable gelPrepare a 2 % solution of the sample by heating it in a boiling water bath for 30 min, with continuous agitation and then cooling the solution to room temperature. For each g of the sample used to prepare 30 g of the 2 % solution, add 1 ml of 10 % potassium carbonate solution to the fully hydrated sample at ambient temperature. Heat the mixture in a water bath to 85 °C, and maintain for 2 h without agitation. Under these conditions a thermally stable gel is formed
C.Viscosity (1 % solution)Not less than 20 kgm-1s-1 at 25 °C
Loss on dryingNot more than 8 % (105 °C, 3h)
StarchNot more than 1 %
ProteinNot more than 1,5 % (N × 5,7)Determine nitrogen by Kjeldahl method. The percentage of nitrogen in the sample multiplied by 5,7 gives the percent of protein in the sample
Ether-soluble materialNot more than 0,5 %
Sulphite (as SO2)Not more than 4 mg/kg
ChlorideNot more than 0,02 %
50 % Alcohol-solubleNot more than 2,0 % material
Total ashNot more than 2,0 % (800 °C, 3 to 4h)
LeadNot more than 1 mg/kg
Salmonella spp.Absent in 12,5 g
E. coliAbsent in 5 g
E 504(ii) MAGNESIUM HYDROXIDE CARBONATE
DefinitionIdentificationPurity
SynonymsMagnesium hydrogen carbonate, magnesium subcarbonate (light or heavy), hydrated basic magnesium carbonate, magnesium carbonate hydroxide
Chemical nameMagnesium carbonate hydroxide hydrated
EINECS235-192-7
Chemical formula4MgCO3Mg(OH)25H2O
Molecular weight485
AssayMg content not less than 40,0 % and not more than 45,0 % calculated as MgO
DescriptionLight, white friable mass or bulky white powder
A.Positive tests for magnesium and for carbonate
B.SolubilityPractically insoluble in water. Insoluble in ethanol
Acid insoluble matterNot more than 0,05 %
Water soluble matterNot more than 1,0 %
CalciumNot more than 1,0 %
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
E 553b TALC
IdentificationPurity
SynonymsTalcum
DefinitionNaturally occurring form of hydrous magnesium silicate containing varying proportions of such associated minerals as alpha-quartz, calcite, chlorite, dolomite, magnesite, and phlogopite
Chemical nameMagnesium hydrogen metasilicate
EINECS238-877-9
Chemical formulaMg3(Si4O10)(OH)2
Molecular weight379,22
DescriptionLight, homogeneous, white or almost white powder, greasy to the touch
A.IR absorptionCharacteristic peaks at 3677, 1018 and 669 cm-1
B.X-ray diffractionPeaks at 9,34/4,66/3,12 Å
C.SolubilityInsoluble in water and ethanol
Loss on dryingNot more than 0,5 % (105 °C, 1h)
Acid-soluble matterNot more than 6 %
Water-soluble matterNot more than 0,2 %
Acid-soluble ironNot detectable
ArsenicNot more than 10 mg/kg
LeadNot more than 5 mg/kg
E 554 SODIUM ALUMINIUM SILICATE
DefinitionIdentificationPurity
SynonymsSodium silicoaluminate, sodium aluminosilicate, aluminium sodium silicate
Chemical nameSodium aluminium silicate
AssayContent on the anhydrous basis:as SiO2 not less than 66,0 % and not more than 88,0 %as Al2O3 not less than 5,0 % and not more than 15,0 %
DescriptionFine white amorphous powder or beads
A.Positive tests for sodium, for aluminium and for silicate
B.pH of a 5 % slurryBetween 6,5 and 11,5
Loss on dryingNot more than 8,0 % (105 °C, 2h)
Loss on ignitionNot less than 5,0 % and not more than 11,0 % on the anhydrous basis (1000 °C, constant weight)
SodiumNot less than 5 % and not more than 8,5 % (as Na2O) on the anhydrous basis
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
E 555 POTASSIUM ALUMINIUM SILICATE
IdentificationPurity
SynonymsMica
DefinitionNatural mica consists of mainly potassium aluminium silicate (muscovite)
EINECS310-127-6
Chemical namePotassium aluminium silicate
Chemical formulaeKAl2[AlSi3O10](OH)2
Molecular weight398
AssayContent not less than 98 %
DescriptionLight grey to white crystalline platelets or powder
A.SolubilityInsoluble in water, diluted acids and alkali and organic solvents
Loss on dryingNot more than 0,5 % (105 °C, 2h)
AntimonyNot more than 20 mg/kg
ZincNot more than 25 mg/kg
BariumNot more than 25 mg/kg
ChromiumNot more than 100 mg/kg
CopperNot more than 25 mg/kg
NickelNot more than 50 mg/kg
ArsenicNot more than 3 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 2 mg/kg
LeadNot more than 10 mg/kg
E 556 CALCIUM ALUMINIUM SILICATE
DefinitionIdentificationPurity
SynonymsCalcium aluminosilicate, calcium silicoaluminate, aluminium calcium silicate
Chemical nameCalcium aluminium silicate
AssayContent on the anhydrous basis:as SiO2 not less than 44,0 % and not more than 50,0 %as Al2O3 not less than 3,0 % and not more than 5,0 %as CaO not less than 32,0 % and not more than 38,0 %
DescriptionFine white, free-flowing powder
A.Positive tests for calcium, for aluminium and for silicate
Loss on dryingNot more than 10,0 % (105 °C, 2h)
Loss on ignitionNot less than 14,0 % and not more than 18,0 on the anhydrous basis (1000 °C, constant weight)
FluorideNot more than 50 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
E 558 BENTONITE
IdentificationPurity
DefinitionBentonite is a natural clay containing a high proportion of montmorillonite, a native hydrated aluminium silicate in which some aluminium and silicon atoms were naturally replaced by other atoms such as magnesium and iron. Calcium and sodium ions are trapped between the mineral layers. There are four common types of bentonite: natural sodium bentonite, natural calcium bentonite, sodium-activated bentonite and acid-activated bentonite
EINECS215-108-5
Chemical formula(Al, Mg)8(Si4O10) 4(OH)8 · 12H2O
Molecular weight819
AssayMontmorillonite content not less than 80 %
DescriptionVery fine, yellowish or greyish white powder or granules. The structure of bentonite allows it to absorb water in its structure and on its external surface (swelling properties)
A.Methylene blue test
B.X-Ray diffractionCharacteristic peaks at 12,5/15 A
C.IR absorptionPeaks at 428/470/530/1110-1020/37503400 cm-1
Loss on dryingNot more than 15,0 % (105 °C, 2h)
ArsenicNot more than 2 mg/kg
LeadNot more than 20 mg/kg
E 559 ALUMINIUM SILICATE (KAOLIN)
IdentificationPurity
SynonymsKaolin, light or heavy
DefinitionAluminium silicate hydrous (kaolin) is a purified white plastic clay composed of kaolinite, potassium aluminium silicate, feldspar and quartz. Processing should not include calcination
EINECS215-286-4 (kaolinite)
Chemical formulaAl2Si2O5(OH)4 (kaolinite)
Molecular weight264
AssayContent not less than 90 % (sum of silica and alumina, after ignition)Silica (SiO2)Between 45 % and 55 %Alumina (Al2O3)Between 30 % and 39 %
DescriptionFine, white or greyish white, unctuous powder. Kaolin is made up of loose aggregations of randomly oriented stacks of kaolinite flakes or of individual hexagonal flakes
A.Positive tests for alumina and for silicate
B.X-ray diffraction:characteristic peaks at 7,18/3,58/2,38/1,78 Å
C.IR absorption:peaks at 3700 and 3620 cm-1
Loss on ignitionBetween 10 and 14 % (1000 °C, constant weight)
Water soluble matterNot more than 0,3 %
Acid soluble matterNot more than 2,0 %
IronNot more than 5 %
Potassium oxide (K2O)Not more than 5 %
CarbonNot more than 0,5 %
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
E 620 GLUTAMIC ACID
DefinitionIdentificationPurity
SynonymsL-Glutamic acid, L-α-aminoglutaric acid
Chemical nameL-Glutamic acid, L-2-amino-pentanedioic acid
EINECS200-293-7
Chemical formulaC5H9NO4
Molecular weight147,13
AssayContent not less than 99,0 % and not more than 101,0 % on the anhydrous basis
DescriptionWhite crystals or crystalline powder
A.Positive test for glutamic acid by thin layer chromatography
B.Specific rotation [α]D20Between + 31,5° and + 32,2°(10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
C.pH of a saturated solutionBetween 3,0 and 3,5
Loss on dryingNot more than 0,2 % (80 °C, 3h)
Sulphated ashNot more than 0,2 %
ChlorideNot more than 0,2 %
Pyrrolidone carboxylic acidNot more than 0,2 %
LeadNot more than 2 mg/kg
E 621 MONOSODIUM GLUTAMATE
DefinitionIdentificationPurity
SynonymsSodium glutamate, MSG
Chemical nameMonosodium L-glutamate monohydrate
EINECS205-538-1
Chemical formulaC5H8NaNO4 · H2O
Molecular weight187,13
AssayContent not less than 99,0 % and not more than 101,0 % on the anhydrous basis
DescriptionWhite, practically odourless crystals or crystalline powder
A.Positive test for sodium
B.Positive test for glutamic acid by thin-layer chromatography
C.Specific rotation [α]D20Between + 24,8° and + 25,3°(10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
D.pH of a 5 % solutionBetween 6,7 and 7,2
Loss on dryingNot more than 0,5 % (98 °C, 5h)
ChlorideNot more than 0,2 %
Pyrrolidone carboxylic acidNot more than 0,2 %
LeadNot more than 2 mg/kg
E 622 MONOPOTASSIUM GLUTAMATE
DefinitionIdentificationPurity
SynonymsPotassium glutamate, MPG
Chemical nameMonopotassium L-glutamate monohydrate
EINECS243-094-0
Chemical formulaC5H8KNO4 · H2O
Molecular weight203,24
AssayContent not less than 99,0 % and not more than 101,0 % on the anhydrous basis
DescriptionWhite, practically odourless crystals or crystalline powder
A.Positive test for potassium
B.Positive test for glutamic acid by thin-layer chromatography
C.Specific rotation [α]D20Between + 22,5° and + 24,0°(10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
D.pH of a 2 % solutionBetween 6,7 and 7,3
Loss on dryingNot more than 0,2 % (80 °C, 5h)
ChlorideNot more than 0,2 %
Pyrrolidone carboxylic acidNot more than 0,2 %
LeadNot more than 2 mg/kg
E 623 CALCIUM DIGLUTAMATE
DefinitionIdentificationPurity
SynonymsCalcium glutamate
Chemical nameMonocalcium di-L-glutamate
EINECS242-905-5
Chemical formulaC10H16CaN2O8 · x H2O (x = 0, 1, 2 or 4)
Molecular weight332,32 (anhydrous)
AssayContent not less than 98,0 % and not more than 102,0 % on the anhydrous basis
DescriptionWhite, practically odourless crystals or crystalline powder
A.Positive test for calcium
B.Positive test for glutamic acid by thin-layer chromatography
C.Specific rotation [α]D20Between + 27,4 and + 29,2 (for calcium diglutamate with x = 4) (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
WaterNot more than 19,0 % (for calcium diglutamate with x = 4) (Karl Fischer)
ChlorideNot more than 0,2 %
Pyrrolidone carboxylic acidNot more than 0,2 %
LeadNot more than 2 mg/kg
E 624 MONOAMMONIUM GLUTAMATE
DefinitionIdentificationPurity
SynonymsAmmonium glutamate
Chemical nameMonoammonium L-glutamate monohydrate
EINECS231-447-1
Chemical formulaC5H12N2O4 · H2O
Molecular weight182,18
AssayContent not less than 99,0 % and not more 101,0 % on the anhydrous basis
DescriptionWhite, practically odourless crystals or crystalline powder
A.Positive test for ammonium
B.Positive test for glutamic acid by thin-layer chromatography
C.Specific rotation [α]D20Between + 25,4° and + 26,4°(10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
D.pH of a 5 % solutionBetween 6,0 and 7,0
Loss on dryingNot more than 0,5 % (50 °C, 4h)
Sulphated ashNot more than 0,1 %
Pyrrolidone carboxylic acidNot more than 0,2 %
LeadNot more than 2 mg/kg
E 625 MAGNESIUM DIGLUTAMATE
DefinitionIdentificationPurity
SynonymsMagnesium glutamate
Chemical nameMonomagnesium di-L-glutamate tetrahydrate
EINECS242-413-0
Chemical formulaC10H16MgN2O8 · 4H2O
Molecular weight388,62
AssayContent not less than 95,0 % and not more than 105,0 % on the anhydrous basis
DescriptionOdourless, white or off-white crystals or powder
A.Positive test for magnesium
B.Positive test for glutamic acid by thin-layer chromatography
C.Specific rotation [α]D20Between + 23,8° and + 24,4°(10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
D.pH of a 10 % solutionBetween 6,4 and 7,5
WaterNot more than 24 % (Karl Fischer)
ChlorideNot more than 0,2 %
Pyrrolidone carboxylic acidNot more than 0,2 %
LeadNot more than 2 mg/kg
E 626 GUANYLIC ACID
DefinitionIdentificationPurity
SynonymsGuanylic acid
Chemical nameGuanosine-5'-monophosphoric acid
EINECS201-598-8
Chemical formulaC10H14N5O8P
Molecular weight363,22
AssayContent not less than 97,0 % on the anhydrous basis
DescriptionOdourless, colourless or white crystals or white crystalline powder
A.Positive test for ribose and for organic phosphate
B.pH of a 0,25 % solutionBetween 1,5 and 2,5
C.Spectrometry:maximum absorption of a 20 mg/l solution in 0,01N HCl at 256 nm
Loss on dryingNot more than 1,5 % (120 °C, 4h)
Other nucleotidesNot detectable by thin-layer chromatography
LeadNot more than 2 mg/kg
E 627 DISODIUM GUANYLATE
DefinitionIdentificationPurity
SynonymsSodium guanylate, sodium 5'-guanylate
Chemical nameDisodium guanosine-5'-monophosphate
EINECS221-849-5
Chemical formulaC10H12N5Na2O8P · x H2O (x = ca. 7)
Molecular weight407,19 (anhydrous)
AssayContent not less than 97,0 % on the anhydrous basis
DescriptionOdourless, colourless or white crystals or white crystalline powder
A.Positive test for ribose, for organic phosphate, and for sodium
B.pH of a 5 % solutionBetween 7,0 and 8,5
C.Spectrometry:maximum absorption of a 20 mg/l solution in 0,01N HCl at 256 nm
Loss on dryingNot more than 25 % (120 °C, 4h)
Other nucleotidesNot detectable by thin-layer chromatography
LeadNot more than 2 mg/kg
E 628 DIPOTASSIUM GUANYLATE
DefinitionIdentificationPurity
SynonymsPotassium guanylate, potassium 5'-guanylate
Chemical nameDipotassium guanosine-5'-monophosphate
EINECS226-914-1
Chemical formulaC10H12K2N5O8P
Molecular weight439,40
AssayContent not less than 97,0 % on the anhydrous basis
DescriptionOdourless, colourless or white crystals or white crystalline powder
A.Positive test for ribose, for organic phosphate, and for potassium
B.pH of a 5 % solutionBetween 7,0 and 8,5
C.Spectrometry:maximum absorption of a 20 mg/l solution in 0,01N HCl at 256 nm
Loss on dryingNot more than 5 % (120 °C, 4h)
Other nucleotidesNot detectable by thin-layer chromatography
LeadNot more than 2 mg/kg
E 629 CALCIUM GUANYLATE
DefinitionIdentificationPurity
SynonymsCalcium 5'-guanylate
Chemical nameCalcium guanosine-5'-monophosphate
Chemical formulaC10H12CaN5O8P · nH2O
Molecular weight401,20 (anhydrous)
AssayContent not less than 97,0 % on the anhydrous basis
DescriptionOdourless, white or off-white crystals or powder
A.Positive test for ribose, for organic phosphate, and for calcium
B.pH of a 0,05 % solutionBetween 7,0 and 8,0
C.Spectrometry:maximum absorption of a 20 mg/l solution in 0,01N HCl at 256 nm
Loss on dryingNot more than 23,0 % (120 °C, 4h)
Other nucleotidesNot detectable by thin-layer chromatography
LeadNot more than 2 mg/kg
E 630 INOSINIC ACID
DefinitionIdentificationPurity
Synonyms5'-Inosinic acid
Chemical nameInosine-5'-monophosphoric acid
EINECS205-045-1
Chemical formulaC10H13N4O8P
Molecular weight348,21
AssayContent not less than 97,0 % on the anhydrous basis
DescriptionOdourless, colourless or white crystals or powder
A.Positive test for ribose, and for organic phosphate
B.pH of a 5 % solutionBetween 1,0 and 2,0
C.Spectrometry:maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm
Loss on dryingNot more than 3,0 % (120 °C, 4h)
Other nucleotidesNot detectable by thin-layer chromatography
LeadNot more than 2 mg/kg
E 631 DISODIUM INOSINATE
DefinitionIdentificationPurity
SynonymsSodium inosinate, sodium 5'-inosinate
Chemical nameDisodium inosine-5'-monophosphate
EINECS225-146-4
Chemical formulaC10H11N4Na2O8P · H2O
Molecular weight392,17 (anhydrous)
AssayContent not less than 97,0 % on the anhydrous basis
DescriptionOdourless, colourless or white crystals or powder
A.Positive test for ribose, and for organic phosphate and for sodium
B.pH of a 5 % solutionBetween 7,0 and 8,5
C.Spectrometry:maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm
WaterNot more than 28,5 % (Karl Fischer)
Other nucleotidesNot detectable by thin-layer chromatography
LeadNot more than 2 mg/kg
E 632 DIPOTASSIUM INOSINATE
DefinitionIdentificationPurity
SynonymsPotassium inosinate, potassium 5'-inosinate
Chemical nameDipotassium inosine-5'-monophosphate
EINECS243-652-3
Chemical formulaC10H11K2N4O8P
Molecular weight424,39
AssayContent not less than 97,0 % on the anhydrous basis
DescriptionOdourless, colourless or white crystals or powder
A.Positive test for ribose, and for organic phosphate and for potassium
B.pH of a 5 % solutionBetween 7,0 and 8,5
C.Spectrometry:maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm
WaterNot more than 10,0 % (Karl Fischer)
Other nucleotidesNot detectable by thin-layer chromatography
LeadNot more than 2 mg/kg
E 633 CALCIUM INOSINATE
DefinitionIdentificationPurity
SynonymsCalcium 5'-inosinate
Chemical nameCalcium inosine-5'-monophosphate
Chemical formulaC10H11CaN4O8P · nH2O
Molecular weight386,19 (anhydrous)
AssayContent not less than 97,0 % on the anhydrous basis
DescriptionOdourless, colourless or white crystals or powder
A.Positive test for ribose, and for organic phosphate and for calcium
B.pH of a 0,05 % solutionBetween 7,0 and 8,0
C.Spectrometry:maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm
WaterNot more than 23,0 % (Karl Fischer)
Other nucleotidesNot detectable by thin-layer chromatography
LeadNot more than 2 mg/kg
E 634 CALCIUM 5'-RIBONUCLEOTIDE
DefinitionIdentificationPurity
Chemical nameCalcium 5'-ribonucleotide is essentially a mixture of calcium inosine-5'-monophosphate and calcium guanosine-5'-monophosphate
Chemical formulaC10H11N4CaO8P · nH2O yC10H12N5CaO8P · nH2O
AssayContent of both major components not less than 97,0 %, and of each component not less than 47,0 % and not more than 53 %, in every case on the anhydrous basis
DescriptionOdourless, white or nearly white crystals or powder
A.Positive test for ribose, and for organic phosphate and for calcium
B.pH of a 0,05 % solutionBetween 7,0 and 8,0
WaterNot more than 23,0 % (Karl Fischer)
Other nucleotidesNot detectable by thin-layer chromatography
LeadNot more than 2 mg/kg
E 635 DISODIUM 5'-RIBONUCLEOTIDE
DefinitionIdentificationPurity
SynonymsSodium 5'-ribonucleotide
Chemical nameDisodium 5'-ribonucleotide is essentially a mixture of disodium inosine-5'-monophosphate and disodium guanosine-5'-monophosphate
Chemical formulaC10H11N4O8P · nH2O andC10H12N5Na2O8P · nH2O
AssayContent of both major components not less than 97,0 %, and of each component not less than 47,0 % and not more than 53 %, in every case on the anhydrous basis
DescriptionOdourless, white or nearly white crystals or powder
A.Positive test for ribose, and for organic phosphate and for sodium
B.pH of a 5 % solutionBetween 7,0 and 8,5
WaterNot more than 26,0 % (Karl Fischer)
Other nucleotidesNot detectable by thin-layer chromatography
LeadNot more than 2 mg/kg
E 905 MICROCRYSTALLINE WAX
IdentificationPurity
SynonymsPetroleum wax
DefinitionMicrocrystalline wax is a refined mixture of solid, saturated hydrocarbons, mainly branched paraffin, obtained from petroleum
DescriptionWhite to amber, odourless wax
A.SolubilityInsoluble in water, very slightly soluble in ethanol
B.Refractive IndexnD1001,434-1,448
Molecular weightAverage not less than 500
Viscosity at 100 °CNot less than 1,1 · 10-5 m2s-1
Residue on ignitionNot more than 0,1 %
Carbon number at 5 % distillation pointNot more than 5 % of molecules with carbon number less than 25
ColourPasses test
SulphurNot more than 0,4 %
ArsenicNot more than 3 mg/kg
LeadNot more than 3 mg/kg
Polycyclic aromatic compoundsThe polycyclic aromatic hydrocarbons, obtained by extraction with dimethyl sulfoxide, shall meet the following ultraviolet absorbency limits:
nmMaximum absorbance per cm path length
280-2890,15
290-2990,12
300-3590,08
360-4000,02
E 912 MONTAN ACID ESTERS
IdentificationPurity
DefinitionMontan acids and/or esters with ethylene glycol and/or 1,3-butanediol and/or glycerol
Chemical nameMontan acid esters
DescriptionAlmost white to yellowish flakes, powder, granules or pellets
A.Density (20 °C)Between 0,98 and 1,05
B.Drop pointGreater than 77 °C
Acid valueNot more than 40
GlycerolNot more than 1 % (by gas chromatography)
Other polyolsNot more than 1 % (by gas chromatography)
Other wax typesNot detectable (by differential scanning calorimetry and/or infrared spectroscopy)
ArsenicNot more than 2 mg/kg
ChromiumNot more than 3 mg/kg
LeadNot more than 2 mg/kg
E 914 OXIDISED POLYETHYLENE WAX
IdentificationPurity
DefinitionPolar reaction products from mild oxidation of polyethylene
Chemical nameOxidised polyethylene
DescriptionAlmost white flakes, powder, granules or pellets
A.Density (20 °C)Between 0,92 and 1,05
B.Drop pointGreater than 95 °C
Acid valueNot more than 70
Viscosity at 120 °CNot less than 8,1·10-5 m2s-1
Other wax typesNot detectable (by differential scanning calorimetry and/or infrared spectroscopy)
OxygenNot more than 9,5 %
ChromiumNot more than 5 mg/kg
LeadNot more than 2 mg/kg
E 950 ACESULFAME KPurity criteria for this additive are the same as set out for this additive in the Annex to Directive 95/31/EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs.E 951 ASPARTAMEPurity criteria for this additive are the same as set out for this additive in the Annex to Directive 95/31/EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs.E 953 ISOMALTPurity criteria for this additive are the same as set out for this additive in the Annex to Directive 95/31/EC, as amended by Directive 98/66/EC, laying down specific criteria of purity concerning sweeteners for use in foodstuffs.E 957 THAUMATINPurity criteria for this additive are the same as set out for this additive in the Annex to Directive 95/31/EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs.E 959 NEOHESPERIDINE DIHYDROCHALCONEPurity criteria for this additive are the same as set out for this additive in the Annex to Directive 95/31/EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs.E 965(i) MALTITOLPurity criteria for this additive are the same as set out for this additive in the Annex to Directive 95/31/EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs.E 965(ii) MALTITOL SYRUPPurity criteria for this additive are the same as set out for this additive in the Annex to Directive 95/31/EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs.E 966 LACTITOLPurity criteria for this additive are the same as set out for this additive in the Annex to Directive 95/31/EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs.E 967 XYLITOLPurity criteria for this additive are the same as set out for this additive in the Annex to Directive 95/31/EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs.