EN Official Journal of the European Union L 253/1

COMMISSION DIRECTIVE 2008/84/EC

of 27 August 2008

laying down specific purity criteria on food additives other than colours and sweeteners

(Text with EEA relevance)

(Codified version)

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 authorised for use in foodstuffs intended for human consumption (1), and in particular Article 3(3)(a) thereof,

Whereas:

(1) Commission Directive 96/77/EC of 2 December 1996 laying down specific purity criteria on food additives other than colours and sweeteners (2) has been substantially amended several times (3). In the interests of clarity and rationality the said Directive should be codified.

(2) 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 sweeteners (4).

(3) It is necessary to take into account 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).

(4) Food additives prepared by production methods or starting materials significantly different from those evaluated by the Scientific Committee for Food or different from those mentioned in this Directive should be submitted for safety evaluation by the European Food Safety Authority with emphasis on the purity criteria.

(5) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health.

(6) This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex II, part B,

HAS ADOPTED THIS DIRECTIVE:

Article 1

The 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 Annex I to this Directive.

Article 2

Directive 96/77/EC, as amended by the Directives listed in Annex II, part A, is repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law set out in Annex II, part B.

References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex III.

Article 3

This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 27 August 2008. For the Commission The President José Manuel BARROSO

(1) OJ L 40, 11.2.1989, p. 27.

(2) OJ L 339, 30.12.1996, p. 1.

(3) See Annex II, part A.

(4) OJ L 61, 18.3.1995, p. 1.

ANNEX I Ethylene oxide may not be used for sterilising purposes in food additives. E 170 (i) CALCIUM CARBONATE Purity criteria for this additive are the same as set out for this additive in the Annex to Commission Directive 95/45/EC (1). E 200 SORBIC ACID Definition Chemical name Sorbic acid Trans, trans-2,4-hexadienoic acid Einecs 203-768-7 Chemical formula C6H8O2 Molecular weight 112,12 Assay Content not less than 99 % on the anhydrous basis Description Colourless needles or white free flowing powder, having a slight characteristic odour and showing no change in colour after heating for 90 minutes at 105 oC Identification A. Melting range Between 133 oC and 135 oC, after vacuum drying for four hours in a sulphuric acid desiccator B. Spectrometry An isopropanol solution (1 in 4 000 000) shows absorbance maximum at 254 ± 2 nm C. Positive test for double bonds D. Sublimation point 80 oC Purity Water content Not more than 0,5 % (Karl Fischer method) Sulphated ash Not more than 0,2 % Aldehydes Not more than 0,1 % (as formaldehyde) Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 202 POTASSIUM SORBATE Definition Chemical name Potassium sorbate Potassium (E, E)-2,4-hexadienoate Potassium salt of trans, trans 2,4-hexadienoic acid Einecs 246-376-1 Chemical formula C6H7O2K Molecular weight 150,22 Assay Content not less than 99 % on the dried basis Description White crystalline powder showing no change in colour after heating for 90 minutes at 105 oC Identification A. Melting range of sorbic acid isolated by acidification and not recrystallised 133 oC to 135 oC after vacuum drying in a sulphuric acid desiccator B. Positive tests for potassium and for double bonds Purity Loss on drying Not more than 1,0 % (105 oC, 3h) Acidity or alkalinity Not more than about 1,0 % (as sorbic acid or K2CO3) Aldehydes Not more than 0,1 %, calculated as formaldehyde Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 203 CALCIUM SORBATE Definition Chemical name Calcium sorbate Calcium salts of trans, trans-2,4-hexadienoic acid Einecs 231-321-6 Chemical formula C12H14O4Ca Molecular weight 262,32 Assay Content not less than 98 % on the dried basis Description Fine white crystalline powder not showing any change in colour after heating at 105 oC for 90 minutes Identification A. Melting range of sorbic acid isolated by acidification and not recrystallised 133 oC to 135 oC after vacuum drying in a sulphuric acid desiccator B. Positive tests for calcium and for double bonds Purity Loss on drying Not more than 2,0 %, determined by vacuum drying for four hours in a sulphuric acid desiccator Aldehydes Not more than 0,1 % (as formaldehyde) Fluoride Not more than 10 mg/kg Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 210 BENZOIC ACID Definition Chemical name Benzoic acid Benzenecarboxylic acid Phenylcarboxylic acid Einecs 200-618-2 Chemical formula C7H6O2 Molecular weight 122,12 Assay Content not less than 99,5 % on the anhydrous basis Description White crystalline powder Identification A. Melting range 121,5 oC to 123,5 oC B. Positive sublimation test and test for benzoate Purity Loss on drying Not more than 0,5 % after drying for three hours over sulphuric acid pH About 4 (solution in water) Sulphated ash Not more than 0,05 % Chlorinated organic compounds Not more than 0,07 % expressed as chloride corresponding to 0,3 % expressed as monochlorobenzoic acid Readily oxidisable substances Add 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 carbonisable substances A 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 (3), 0,3 ml of ferric chloride TSC (4), 0,1 ml of copper sulphate TSC (5) and 4,4 ml of water Polycyclic acids On fractional acidification of a neutralised solution of benzoic acid, the first precipitate must not have a different melting point from that of the benzoic acid Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 211 SODIUM BENZOATE Definition Chemical name Sodium benzoate Sodium salt of benzenecarboxylic acid Sodium salt of phenylcarboxylic acid Einecs 208-534-8 Chemical formula C7H5O2Na Molecular weight 144,11 Assay Not less than 99 % of C7H5O2Na, after drying at 105 oC for four hours Description A white, almost odourless, crystalline powder or granules Identification A. Solubility Freely soluble in water, sparingly soluble in ethanol B. Melting range for benzoic acid Melting range of benzoic acid isolated by acidification and not recrystallised 121,5 oC to 123,5 oC, after drying in a sulphuric acid desiccator C. Positive tests for benzoate and for sodium Purity Loss on drying Not more than 1,5 % after drying at 105 oC for four hours Readily oxidisable substances Add 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 acids On fractional acidification of a (neutralised) solution of sodium benzoate, the first precipitate must not have a different melting range from that of benzoic acid Chlorinated organic compounds Not more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monochlorobenzoic acid Degree of acidity or alkalinity Neutralisation 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 Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 212 POTASSIUM BENZOATE Definition Chemical name Potassium benzoate Potassium salt of benzenecarboxylic acid Potassium salt of phenylcarboxylic acid Einecs 209-481-3 Chemical formula C7H5KO2·3H2O Molecular weight 214,27 Assay Content not less than 99 % C7H5KO2 after drying at 105 oC to constant weight Description White crystalline powder Identification A. Melting range of benzoic acid isolated by acidification and not recrystallised 121,5 oC to 123,5 oC, after vacuum drying in a sulphuric acid desiccator B. Positive tests for benzoate and for potassium Purity Loss on drying Not more than 26,5 %, determined by drying at 105 oC Chlorinated organic compounds Not more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monochlorobenzoic acid Readily oxidisable substances Add 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 carbonisable substances A 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 acids On fractional acidification of a (neutralised) solution of potassium benzoate, the first precipitate must not have a different melting range from that of benzoic acid Degree of acidity or alkalinity Neutralisation 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 Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 213 CALCIUM BENZOATE Synonyms Monocalcium benzoate Definition Chemical name Calcium benzoate Calcium dibenzoate Einecs 218-235-4 Chemical formula Anhydrous: C14H10O4Ca Monohydrate: C14H10O4Ca· H2O Trihydrate: C14H10O4Ca· 3H2O Molecular weight Anhydrous: 282,31 Monohydrate: 300,32 Trihydrate: 336,36 Assay Content not less than 99 % after drying at 105 oC Description White or colourless crystals, or white powder Identification A. Melting range of benzoic acid isolated by acidification and not recrystallised 121,5 oC to 123,5 oC, after vacuum drying in a sulphuric acid desiccator B. Positive tests for benzoate and for calcium Purity Loss on drying Not more than 17,5 % determined by drying at 105 oC to constant weight Water insoluble matter Not more than 0,3 % Chlorinated organic compounds Not more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monochlorobenzoic acids Readily oxidisable substances Add 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 carbonisable substances 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 acids On fractional acidification of a (neutralised) solution of calcium benzoate, the first precipitate must not be a different melting range from that of benzoic acid Degree of acidity or alkalinity Neutralisation 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 Fluoride Not more than 10 mg/kg Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 214 ETHYL p-HYDROXYBENZOATE Synonyms Ethylparaben Ethyl p-oxybenzoate Definition Chemical name Ethyl-p-hydroxybenzoate Ethyl ester of p-hydroxybenzoic acid Einecs 204-399-4 Chemical formula C9H10O3 Molecular weight 166,8 Assay Content not less than 99,5 % after drying for two hours at 80 oC Description Almost odourless, small, colourless crystals or a white, crystalline powder Identification A. Melting range 115 oC to 118 oC B. Positive test for p-hydroxybenzoate Melting range of p-hydroxybenzoic acid isolated by acidification and not recrystallised: 213 oC to 217 oC, after vacuum drying in a sulphuric acid desiccator C. Positive test for alcohol Purity Loss on drying Not more than 0,5 % after drying for two hours at 80 oC Sulphated ash Not more than 0,05 % p-Hydroxybenzoic acid and salicylic acid Not more than 0,35 % expressed as p-hydroxybenzoic acid Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 215 SODIUM ETHYL p-HYDROXYBENZOATE Definition Chemical name Sodium ethyl p-hydroxybenzoate Sodium compound of the ethyl ester of p-hydroxybenzoic acid Einecs 252-487-6 Chemical formula C9H9O3Na Molecular weight 188,8 Assay Content of ethylester of p-hydroxybenzoic acid not less than 83 % on the anhydrous basis Description White, crystalline hygroscopic powder Identification A. Melting range 115 oC to 118 oC, after vacuum drying in a sulphuric acid desiccator B. Positive test for p-hydroxybenzoate Melting range of p-hydroxybenzoic acid derived from the sample is 213 oC to 217 oC C. Positive test for sodium D. pH of a 0,1 % aqueous solution must be between 9,9 and 10,3 Purity Loss on drying Not more than 5 %, determined by vacuum drying in a sulphuric acid desiccator Sulphated ash 37 to 39 % p-Hydroxybenzoic acid and salicylic acid Not more than 0,35 % expressed as p-hydroxybenzoic acid Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 218 METHYL p-HYDROXYBENZOATE Synonyms Methylparaben Methyl-p-oxybenzoate Definition Chemical name Methyl p-hydroxybenzoate Methyl ester of p-hydroxybenzoic acid Einecs 243-171-5 Chemical formula C8H8O3 Molecular weight 152,15 Assay Content not less than 99 % after drying for two hours at 80 oC Description Almost odourless, small colourless crystals or white crystalline powder Identification A. Melting range 125 oC to 128 oC B. Positive test for p-hydroxybenzoate Melting range of p-hydroxybenzoic acid derived from the sample is 213 oC to 217 oC after drying for two hours at 80 oC Purity Loss on drying Not more than 0,5 %, after drying for two hours at 80 oC Sulphated ash Not more than 0,05 % p-Hydroxybenzoic acid and salicylic acid Not more than 0,35 % expressed as p-hydroxybenzoic acid Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 219 SODIUM METHYL p-HYDROXYBENZOATE Definition Chemical name Sodium methyl p-hydroxybenzoate Sodium compound of the methylester of p-hydroxybenzoic acid Chemical formula C8H7O3Na Molecular weight 174,15 Assay Content not less than 99,5 % on the anhydrous basis Description White, hygroscopic powder Identification 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 oC for two hours, have a melting range of 125 oC to 128 oC 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 Purity Water content Not more than 5 % (Karl Fischer method) Sulphated ash 40 % to 44,5 % on the anhydrous basis p-Hydroxybenzoic acid and salicylic acid Not more than 0,35 % expressed as p-hydroxybenzoic acid Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 220 SULPHUR DIOXIDE Definition Chemical name Sulphur dioxide Sulphurous acid anhydride Einecs 231-195-2 Chemical formula SO2 Molecular weight 64,07 Assay Content not less than 99 % Description Colourless, non-flammable gas with strong pungent suffocating odour Identification A. Positive test for sulphurous substances Purity Water content Not more than 0,05 % Non-volatile residue Not more than 0,01 % Sulphur trioxide Not more than 0,1 % Selenium Not more than 10 mg/kg Other gases not normally present in the air No trace Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 221 SODIUM SULPHITE Definition Chemical name Sodium sulphite (anhydrous or heptahydrate) Einecs 231-821-4 Chemical formula Anhydrous: Na2SO3 Heptahydrate: Na2SO37H2O Molecular weight Anhydrous: 126,04 Heptahydrate: 252,16 Assay Anhydrous: 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 Description White crystalline powder or colourless crystals Identification 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 Purity Thiosulphate Not more than 0,1 % based on the SO2 content Iron Not more than 50 mg/kg based on the SO2 content Selenium Not more than 10 mg/kg based on the SO2 content Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 222 SODIUM BISULPHITE Definition Chemical name Sodium bisulphite Sodium hydrogen sulphite Einecs 231-921-4 Chemical formula NaHSO3 in aqueous solution Molecular weight 104,06 Assay Content not less than 32 % w/w NaHSO3 Description A clear, colourless to yellow solution Identification A. Positive tests for sulphite and for sodium B. pH of a 10 % aqueous solution between 2,5 and 5,5 Purity Iron Not more than 50 mg/kg of Na2SO3 based on the SO2 content Selenium Not more than 10 mg/kg based on the SO2 content Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 223 SODIUM METABISULPHITE Synonyms Pyrosulphite Sodium pyrosulphite Definition Chemical name Sodium disulphite Disodium pentaoxodisulphate Einecs 231-673-0 Chemical formula Na2S2O5 Molecular weight 190,11 Assay Content not less than 95 % Na2S2O5 and not less than 64 % of SO2 Description White crystals or crystalline powder Identification A. Positive tests for sulphite and for sodium B. pH of a 10 % aqueous solution between 4,0 and 5,5 Purity Thiosulphate Not more than 0,1 % based on the SO2 content Iron Not more than 50 mg/kg based on the SO2 content Selenium Not more than 10 mg/kg based on the SO2 content Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 224 POTASSIUM METABISULPHITE Synonyms Potassium pyrosulphite Definition Chemical name Potassium disulphite Potassium pentaoxo disulphate Einecs 240-795-3 Chemical formula K2S2O5 Molecular weight 222,33 Assay Content not less than 90 % of K2S2O5 and not less than 51,8 % of SO2, the remainder being composed almost entirely of potassium sulphate Description Colourless crystals or white crystalline powder Identification A. Positive tests for sulphite and for potassium Purity Thiosulphate Not more than 0,1 % based on the SO2 content Iron Not more than 50 mg/kg based on the SO2 content Selenium Not more than 10 mg/kg based on the SO2 content Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 226 CALCIUM SULPHITE Definition Chemical name Calcium sulphite Einecs 218-235-4 Chemical formula CaSO3·2H2O Molecular weight 156,17 Assay Content not less than 95 % of CaSO3·2H2O and not less than 39 % of SO2 Description White crystals or white crystalline powder Identification A. Positive tests for sulphite and for calcium Purity Iron Not more than 50 mg/kg based on the SO2 content Selenium Not more than 10 mg/kg based on the SO2 content Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 227 CALCIUM BISULPHITE Definition Chemical name Calcium bisulphite Calcium hydrogen sulphite Einecs 237-423-7 Chemical formula Ca(HSO3)2 Molecular weight 202,22 Assay 6 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] Description Clear greenish-yellow aqueous solution having a distinct odour of sulphur dioxide Identification A. Positive tests for sulphite and for calcium Purity Iron Not more than 50 mg/kg based on the SO2 content Selenium Not more than 10 mg/kg based on the SO2 content Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 228 POTASSIUM BISULPHITE Definition Chemical name Potassium bisulphite Potassium hydrogen sulphite Einecs 231-870-1 Chemical formula KHSO3 in aqueous solution Molecular weight 120,17 Assay Content not less than 280 g KHSO3 per litre (or 150 g SO2 per litre) Description Clear colourless aqueous solution Identification A. Positive tests for sulphite and for potassium Purity Iron Not more than 50 mg/kg based on the SO2 content Selenium Not more than 10 mg/kg based on the SO2 content Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 230 BIPHENYL Synonyms Diphenyl Definition Chemical name 1,1′-biphenyl Phenylbenzene Einecs 202-163-5 Chemical formula C12H10 Molecular weight 154,20 Assay Content not less than 99,8 % Description White or pale yellow to amber crystalline solid having a characteristic odour Identification A. Melting range 68,5 oC to 70,5 oC B. Distillation range It distils completely within a 2,5 oC range between 252,5 oC and 257,5 oC Purity Benzene Not more than 10 mg/kg Aromatic amines Not more than 2 mg/kg (as aniline) Phenol derivatives Not more than 5 mg/kg (as phenol) Readily carbonisable substances Cold 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 derivatives Not more than 0,2 % Polycyclic aromatic hydrocarbons Absent Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 231 ORTHOPHENYLPHENOL Synonyms Orthoxenol Definition Chemical name (1,1'-Biphenyl)-2-ol 2-Hydroxydiphenyl o-Hydroxydiphenyl Einecs 201-993-5 Chemical formula C12H10O Molecular weight 170,20 Assay Content not less than 99 % Description White or slightly yellowish crystalline powder Identification A. Melting range 56 oC to 58 oC B. Positive test for phenolate An ethanolic solution (1 g in 10 ml) produces a green colour on addition of 10 % ferric chloride solution Purity Sulphated ash Not more than 0,05 % Diphenyl ether Not more than 0,3 % p-Phenylphenol Not more than 0,1 % 1-Naphthol Not more than 0,01 % Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 232 SODIUM ORTHOPHENYLPHENOL Synonyms Sodium orthophenylphenate Sodium salt ofo-phenylphenol Definition Chemical name Sodium orthophenylphenol Einecs 205-055-6 Chemical formula C12H9ONa· 4H2O Molecular weight 264,26 Assay Content not less than 97 % of C12H9ONa· 4H2O Description White or slightly yellowish crystalline powder Identification A. Positive tests for phenolate and for sodium B. Melting range of orthophenylphenol isolated by acidification and not recrystallised derived from the sample 56 oC to 58 oC after drying in a sulphuric acid desiccator C. pH of a 2 % aqueous solution must be between 11,1 and 11,8 Purity Diphenylether Not more than 0,3 % p-phenylphenol Not more than 0,1 % 1-naphthol Not more than 0,01 % Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 233 THIABENDAZOLE Definition Chemical name 4-(2-benzimidazolyl)thiazole 2-(4-thiazolyl)-1H-benzimidazole Einecs 205-725-8 Chemical formula C10H7N3S Molecular weight 201,26 Assay Content not less than 98 % on the anhydrous basis Description White, or almost white, odourless powder Identification A. Melting range 296 oC to 303 oC B. Spectrometry Absorption maxima in 0,1 N HCl (0,0005 % w/v) at 302 nm, 258 nm and 243 nm at 302 nm ± 2 nm: approximately 1 230 at 258 nm ± 2 nm: approximately 200 at 243 nm ± 2 nm: approximately 620 Ratio of absorption 243 nm/302 nm = 0,47 to 0,53 Ratio of absorption 258 nm/302 nm = 0,14 to 0,18 Purity Water content Not more than 0,5 % (Karl Fischer method) Sulphated ash Not more than 0,2 % Selenium Not more than 3 mg/kg Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 234 NISIN Definition Nisin consists of several closely related polypeptides produced by natural strains of Streptococcus lactis, Lancefield group N Einecs 215-807-5 Chemical formula C143H230N42O37S7 Molecular weight 3 354 ,12 Assay Nisin 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 % Description White powder Purity Loss on drying Not more than 3 % when dried to constant weight at 102 oC to 103 oC Arsenic Not more than 1 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 235 NATAMYCIN Synonyms Pimaricin Definition Natamycin is a fungicide of the polyene macrolide group, and is produced by natural strains of Streptomyces natalensis or of Streptococcus lactis Einecs 231-683-5 Chemical formula C33H47O13N Molecular weight 665,74 Assay Content not less than 95 % on the anhydrous basis Description White to creamy-white crystalline powder Identification A. Colour reactions On 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. Spectrometry A 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. pH 5,5 to 7,5 (1 % w/v solution in previously neutralised mixture of 20 parts dimethylformamide and 80 parts of water) D. Specific rotation [α]D 20 = + 250o to + 295o (a 1 % w/v solution in glacial acetic acid, at 20 oC and calculated with reference to the dried material) Purity Loss on drying Not more than 8 % (over P2O5, in vacuum at 60 oC to constant weight) Sulphated ash Not more than 0,5 % Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg Microbiological criteria: total viable count Not more than 100/g E 239 HEXAMETHYLENE TETRAMINE Synonyms Hexamine Methenamine Definition Chemical name 1,3,5,7-Tetraazatricyclo [3.3.1.13,7]-decane, hexamethylenetetramine Einecs 202-905-8 Chemical formula C6H12N4 Molecular weight 140,19 Assay Content not less than 99 % on the anhydrous basis Description Colourless or white crystalline powder Identification A. Positive tests for formaldehyde and for ammonia B. Sublimation point approximately 260 oC Purity Loss on drying Not more than 0,5 % after drying at 105 oC in vacuum over P2O5 for two hours Sulphated ash Not more than 0,05 % Sulphates Not more than 0,005 % expressed as SO4 Chlorides Not more than 0,005 % expressed as Cl Ammonium salts Not detectable Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 242 DIMETHYL DICARBONATE Synonyms DMDC Dimethyl pyrocarbonate Definition Chemical name Dimethyl dicarbonate Pyrocarbonic acid dimethyl ester Einecs 224-859-8 Chemical formula C4H6O5 Molecular weight 134,09 Assay Content not less than 99,8 % Description Colourless liquid, decomposes in aqueous solution. It is corrosive to skin and eyes and toxic by inhalation and ingestion Identification A. Decomposition After dilution positive tests for CO2 and methanol B. Melting point 17 oC Boiling point 172 oC with decomposition C. Density 20 oC Approximately 1,25 g/cm3 D. Infrared spectrum Maxima at 1 156 and 1 832 cm- 1 Purity Dimethyl carbonate Not more than 0,2 % Chlorine, total Not more than 3 mg/kg Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 249 POTASSIUM NITRITE Definition Chemical name Potassium nitrite Einecs 231-832-4 Chemical formula KNO2 Molecular weight 85,11 Assay Content not less than 95 % on the anhydrous basis (6) Description White or slightly yellow, deliquescent granules Identification 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 Purity Loss on drying Not more than 3 % after drying for four hours over silica gel Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 250 SODIUM NITRITE Definition Chemical name Sodium nitrite Einecs 231-555-9 Chemical formula NaNO2 Molecular weight 69,00 Assay Content not less than 97 % on the anhydrous basis (7) Description White crystalline powder or yellowish lumps Identification A. Positive tests for nitrite and for sodium Purity Loss on drying Not more than 0,25 % after drying over silica gel for four hours Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 251 SODIUM NITRATE 1. SOLID SODIUM NITRATE Synonyms Chile saltpetre Cubic or soda nitre Definition Chemical name Sodium nitrate Einecs 231-554-3 Chemical formula NaNO3 Molecular weight 85,00 Assay Content not less than 99 % after drying Description White crystalline, slightly hygroscopic powder Identification A. Positive tests for nitrate and for sodium B. pH of a 5 % solution Not less than 5,5 and more than 8,3 Purity Loss on drying Not more than 2 % after drying at 105 oC for four hours Nitrites Not more than 30 mg/kg expressed as NaNO2 Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg E 251 SODIUM NITRATE 2. LIQUID SODIUM NITRATE Definition Liquid 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 name Sodium nitrate Einecs 231-554-3 Chemical formula NaNO3 Molecular weight 85,00 Assay Content between 33,5 % and 40,0 % of NaNO3 Description Clear colourless liquid Identification A. Positive tests for nitrate and for sodium B. pH Not less than 1,5 and not more than 3,5 Purity Free nitric acid Not more than 0,01 % Nitrites Not more than 10 mg/kg expressed as NaNO2 Arsenic Not more than 1 mg/kg Lead Not more than 1 mg/kg Mercury Not more than 0,3 mg/kg This specification refers to a 35 % aqueous solution E 252 POTASSIUM NITRATE Synonyms Chile saltpetre Cubic or soda nitre Definition Chemical name Potassium nitrate Einecs 231-818-8 Chemical formula KNO3 Molecular weight 101,11 Assay Content not less than 99 % on the anhydrous basis Description White crystalline powder or transparent prisms having a cooling, saline, pungent taste Identification A. Positive tests for nitrate and for potassium B. pH of a 5 % solution Not less than 4,5 and not more than 8,5 Purity Loss on drying Not more than 1 % after drying at 105 oC for four hours Nitrites Not more than 20 mg/kg expressed as KNO2 Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 260 ACETIC ACID Definition Chemical name Acetic acid Ethanoic acid Einecs 200-580-7 Chemical formula C2H4O2 Molecular weight 60,05 Assay Content not less than 99,8 % Description Clear, colourless liquid having a pungent, characteristic odour Identification A. Boiling point 118 oC at 760 mm pressure (of mercury) B. Specific gravity About 1,049 C. A one in three solution gives positive tests for acetate D. Solidification point Not lower than 14,5 oC Purity Non-volatile residue Not more than 100 mg/kg Formic acid, formates and other oxidisable substances Not more than 1 000 mg/kg expressed as formic acid Readily oxidisable substances Dilute 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 Arsenic Not more than 1 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 261 POTASSIUM ACETATE Definition Chemical name Potassium acetate Einecs 204-822-2 Chemical formula C2H3O2K Molecular weight 98,14 Assay Content not less than 99 % on the anhydrous basis Description Colourless, deliquescent crystals or a white crystalline powder, odourless or with a faint acetic odour Identification A. pH of a 5 % aqueous solution Not less than 7,5 and not more than 9,0 B. Positive tests for acetate and for potassium Purity Loss on drying Not more than 8 % after drying at 150 oC for two hours Formic acid, formates and other oxidisable substances Not more than 1 000 mg/kg expressed as formic acid Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 262 (i) SODIUM ACETATE Definition Chemical name Sodium acetate Einecs 204-823-8 Chemical formula C2H3NaO2·nH2O (n = 0 or 3) Molecular weight Anhydrous: 82,03 Trihydrate: 136,08 Assay Content (for both of anhydrous and trihydrate form) not less than 98,5 % on the anhydrous basis Description Anhydrous: 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 Identification A. pH of a 1 % aqueous solution Not less than 8,0 and not more than 9,5 B. Positive tests for acetate and for sodium Purity Loss on drying Anhydrous: Not more than 2 % (120 oC, 4 hours) Trihydrate: Between 36 and 42 % (120 oC, 4 hours) Formic acid, formates and other oxidisable substances Not more than 1 000 mg/kg expressed as formic acid Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 262 (ii) SODIUM DIACETATE Definition Sodium diacetate is a molecular compound of sodium acetate and acetic acid Chemical name Sodium hydrogen diacetate Einecs 204-814-9 Chemical formula C4H7NaO4·nH2O (n = 0 or 3) Molecular weight 142,09 (anhydrous) Assay Content 39 to 41 % of free acetic acid and 58 to 60 % of sodium acetate Description White, hygroscopic crystalline solid with an acetic odour Identification A. pH of a 10 % aqueous solution Not less than 4,5 and not more than 5,0 B. Positive tests for acetate and for sodium Purity Water content Not more than 2 % (Karl Fischer method) Formic acid, formates and other oxidisable substances Not more than 1 000 mg/kg expressed as formic acid Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 263 CALCIUM ACETATE Definition Chemical name Calcium acetate Einecs 200-540-9 Chemical formula Anhydrous: C4H6O4Ca Monohydrate: C4H6O4Ca· H2O Molecular weight Anhydrous: 158,17 Monohydrate: 176,18 Assay Content not less than 98 % on the anhydrous basis Description Anhydrous 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 Identification A. pH of a 10 % aqueous solution Not less than 6,0 and not more than 9,0 B. Positive tests for acetate and for calcium Purity Loss on drying Not more than 11 % after drying (155 oC to constant weight, for the monohydrate) Water insoluble matter Not more than 0,3 % Formic acid, formates and other oxidisable substances Not more than 1 000 mg/kg expressed as formic acid Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 270 LACTIC ACID Definition Chemical name Lactic acid 2-Hydroxypropionic acid 1-Hydroxyethane-1-carboxylic acid Einecs 200-018-0 Chemical formula C3H6O3 Molecular weight 90,08 Assay Content not less than 76 % and not more than 84 % Description Colourless 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 Identification A. Positive test for lactate Purity Sulphated ash Not more than 0,1 % Chloride Not more than 0,2 % Sulphate Not more than 0,25 % Iron Not more than 10 mg/kg Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not 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 E 280 PROPIONIC ACID Definition Chemical name Propionic acid Propanoic acid Einecs 201-176-3 Chemical formula C3H6O2 Molecular weight 74,08 Assay Content not less than 99,5 % Description Colourless or slightly yellowish, oily liquid with a slightly pungent odour Indentification A. Melting point - 22 oC B. Distillation range 138,5 oC to 142,5 oC Purity Non-volatile residue Not more than 0,01 % when dried at 140 oC to constant weight Aldehydes Not more than 0,1 % expressed as formaldehyde Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 281 SODIUM PROPIONATE Definition Chemical name Sodium propionate Sodium propanoate Einecs 205-290-4 Chemical formula C3H5O2Na Molecular weight 96,06 Assay Content not less than 99 % after drying for two hours at 105 oC Description White crystalline hygroscopic powder, or a fine white powder Identification A. Positive tests for propionate and for sodium B. pH of a 10 % aqueous solution Not less than 7,5 and not more than 10,5 Purity Loss on drying Not more than 4 % determined by drying for two hours at 105 oC Water insolubles Not more than 0,1 % Iron Not more than 50 mg/kg Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 282 CALCIUM PROPIONATE Definition Chemical name Calcium propionate Einecs 223-795-8 Chemical formula C6H10O4Ca Molecular weight 186,22 Assay Content not less than 99 %, after drying for two hours at 105 oC Description White crystalline powder Identification A. Positive tests for propionate and for calcium B. pH of a 10 % aqueous solution Between 6,0 and 9,0 Purity Loss on drying Not more than 4 %, determined by drying for two hours at 105 oC Water insolubles Not more than 0,3 % Iron Not more than 50 mg/kg Fluoride Not more than 10 mg/kg Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 283 POTASSIUM PROPIONATE Definition Chemical name Potassium propionate Potassium propanoate Einecs 206-323-5 Chemical formula C3H5KO2 Molecular weight 112,17 Assay Content not less than 99 % after drying for two hours at 105 oC Description White crystalline powder Identification A. Positive tests for propionate and for potassium Purity Loss on drying Not more than 4 %, determined by drying for two hours at 105 oC Water-insoluble substances Not more than 0,3 % Iron Not more than 30 mg/kg Fluoride Not more than 10 mg/kg Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 284 BORIC ACID Synonyms Boracic acid Orthoboric acid Borofax Definition Einecs 233-139-2 Chemical formula H3BO3 Molecular weight 61,84 Assay Content not less than 99,5 % Description Colourless, odourless, transparent crystals or white granules or powder; slightly unctuous to the touch; occurs in nature as the mineral sassolite Identification A. Melting point At approximately 171 oC B. Burns with a nice green flame C. pH of a 3,3 % aqueous solution Between 3,8 and 4,8 Purity Peroxides No colour develops with added KI-solution Arsenic Not more than 1 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 285 SODIUM TETRABORATE (BORAX) Synonyms Sodium borate Definition Chemical name Sodium tetraborate Sodium biborate Sodium pyroborate Anhydrous tetraborate Einecs 215-540-4 Chemical formula Na2B4O7 Na2B4O7·10H2O Molecular weight 201,27 Description Powder or glass-like plates becoming opaque on exposure to air; slowly soluble in water Identification A. Melting range Between 171 oC and 175 oC with decomposition Purity Peroxides No colour develops with added KI-solution Arsenic Not more than 1 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 290 CARBON DIOXIDE Synonyms Carbonic acid gas Dry ice (solid form) Carbonic anhydride Definition Chemical name Carbon dioxide Einecs 204-696-9 Chemical formula CO2 Molecular weight 44,01 Assay Content not less than 99 % v/v on the gaseous basis Description A colourless gas under normal environmental conditions with a slight pungent odour. Commercial carbon dioxide is shipped and handled as a liquid in pressurised 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 Identification 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 Purity Acidity 915 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 sulphide 915 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 monoxide Not more than 10 μl/l Oil content Not more than 0,1 mg/l E 296 MALIC ACID Synonyms DL-Malic acid, pomalous acid Definition Chemical name DL-Malic acid, hydroxybutanedioic acid, hydroxysuccinic acid Einecs 230-022-8 Chemical formula C4H6O5 Molecular weight 134,09 Assay Content not less than 99,0 % Description White or nearly white crystalline powder or granules Identification A. Melting range between 127 oC and 132 oC B. Positive test for malate C. Solutions of this substance are optically inactive in all concentrations Purity Sulphated ash Not more than 0,1 % Fumaric acid Not more than 1,0 % Maleic acid Not more than 0,05 % Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg E 297 FUMARIC ACID Definition Chemical name Trans-butenedioic acid, trans-1,2-ethylene-dicarboxylic acid Einecs 203-743-0 Chemical formula C4H4O4 Molecular weight 116,07 Assay Content not less than 99,0 % on the anhydrous basis Description White crystalline powder or granules Identification A. Melting range 286 oC-302 oC (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 oC 3,0-3,2 Purity Loss on drying Not more than 0,5 % (120 oC, 4h) Sulphated ash Not more than 0,1 % Maleic acid Not more than 0,1 % Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg E 300 ASCORBIC ACID Definition Chemical name L-ascorbic acid Ascorbic acid 2,3-Didehydro-L-threo-hexono-1,4-lactone 3-Keto-L-gulofuranolactone Einecs 200-066-2 Chemical formula C6H8O6 Molecular weight 176,13 Assay Ascorbic acid, after drying in a vacuum desiccator over sulphuric acid for 24 hours, contains not less than 99 % of C6H8O6 Description White to pale yellow, odourless crystalline solid Identification A. Melting range Between 189 oC and 193 oC with decomposition B. Positive tests for ascorbic acid Purity Loss on drying Not more than 0,4 % after drying in a vacuum desiccator over sulphuric acid for 24 hours Sulphated ash Not more than 0,1 % Specific rotation [α]D 20 between +20,5o and +21,5o (10 % w/v aqueous solution) pH of a 2 % aqueous solution Between 2,4 and 2,8 Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 301 SODIUM ASCORBATE Definition Chemical name Sodium ascorbate Sodium L-ascorbate 2,3-Didehydro-L-threo-hexono-1,4-lactone sodium enolate 3-Keto-L-gulofurano-lactone sodium enolate Einecs 205-126-1 Chemical formula C6H7O6Na Molecular weight 198,11 Assay Sodium ascorbate, after drying in a vacuum desiccator over sulphuric acid for 24 hours, contains not less than 99 % of C6H7O6Na Description White or almost white, odourless crystalline solid which darkens on exposure to light Identification A. Positive tests for ascorbate and for sodium Purity Loss on drying Not more than 0,25 % after drying in a vacuum desiccator over sulphuric acid for 24 hours Specific rotation [α]D 20 between + 103o and + 106o (10 % w/v aqueous solution) pH of 10 % aqueous solution Between 6,5 and 8,0 Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 302 CALCIUM ASCORBATE Definition Chemical name Calcium ascorbate dihydrate Calcium salt of 2,3-didehydro-L-threo-hexono-1,4-lactone dihydrate Einecs 227-261-5 Chemical formula C12H14O12Ca· 2H2O Molecular weight 426,35 Assay Content not less than 98 % on a volatile matter-free basis Description White to slightly pale greyish-yellow odourless crystalline powder Identification A. Positive tests for ascorbate and for calcium Purity Fluoride Not more than 10 mg/kg (expressed as fluorine) Specific rotation [α]D 20 between + 95o and + 97o (5 % w/v aqueous solution) pH of 10 % aqueous solution Between 6,0 and 7,5 Volatile matter Not more than 0,3 % determined by drying at room temperature for 24 hours in a desiccator containing sulphuric acid or phosphorus pentoxide Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 304 (i) ASCORBYL PALMITATE Definition Chemical name Ascorbyl palmitate L-ascorbyl palmitate 2,3-didehydro-L-threo-hexono-1,4-lactone-6-palmitate 6-palmitoyl-3-keto-L-gulofuranolactone Einecs 205-305-4 Chemical formula C22H38O7 Molecular weight 414,55 Assay Content not less than 98 % on the dried basis Description White or yellowish-white solid with a citrus-like odour Identification A. Melting range Between 107 oC and 117 oC Purity Loss on drying Not more than 2,0 % after drying in a vacuum oven at 56 oC and 60 oC for one hour Sulphated ash Not more than 0,1 % Specific rotation [α]D 20 between + 21o and + 24o (5 % w/v in methanol solution) Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 304 (ii) ASCORBYL STEARATE Definition Chemical name Ascorbyl stearate L-ascorbyl stearate 2,3-didehydro-L-threo-hexono-1,4-lactone-6-stearate 6-stearoyl-3-keto-L-gulofuranolactone Einecs 246-944-9 Chemical formula C24H42O7 Molecular weight 442,6 Assay Content not less than 98 % Description White or yellowish, white solid with a citrus-like odour Identification A. Melting point About 116 oC Purity Loss on drying Not more than 2,0 % after drying in a vacuum oven at 56 oC to 60 oC for one hour Sulphated ash Not more than 0,1 % Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 306 TOCOPHEROL-RICH EXTRACT Definition Product obtained by the vacuum steam distillation of edible vegetable oil products, comprising concentrated tocopherols and tocotrienols Contains tocopherols such as d-α-, d-β-, d-γ- and d-ς-tocopherols Molecular weight 430,71 (d-α-tocopherol) Assay Content not less than 34 % of total tocopherols Description Brownish 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 Identification A. By suitable gas liquid chromatographic method B. Solubility tests Insoluble in water. Soluble in ethanol. Miscible in ether Purity Sulphated ash Not more than 0,1 % Specific rotation [α]D 20 not less than + 20o Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 307 ALPHA-TOCOPHEROL Synonyms DL-α-Tocopherol Definition Chemical name DL-5,7,8-Trimethyltocol DL-2,5,7,8-tetramethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol Einecs 233-466-0 Chemical formula C29H50O2 Molecular weight 430,71 Assay Content not less than 96 % Description Slightly yellow to amber, nearly odourless, clear, viscous oil which oxidises and darkens on exposure to air or light Identification A. Solubility tests Insoluble in water, freely soluble in ethanol, miscible in ether B. Spectro-photometry In absolute ethanol the maximum absorption is about 292 nm Purity Refractive index n D 201,503-1,507 Specific absorption in ethanol (292 nm) 72-76 (0,01 g in 200 ml of absolute ethanol) Sulphated ash Not more than 0,1 % Specific rotation [α]D 25 0o±0,05o (1 in 10 solution in chloroform) Lead Not more than 2 mg/kg E 308 GAMMA-TOCOPHEROL Synonyms dl-γ-Tocopherol Definition Chemical name 2,7,8-trimethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol Einecs 231-523-4 Chemical formula C28H48O2 Molecular weight 416,69 Assay Content not less than 97 % Description Clear, viscous, pale yellow oil which oxidises and darkens on exposure to air or light Identification A. Spectrometry Maximum absorptions in absolute ethanol at about 298 nm and 257 nm Purity Specific absorption in ethanol (298 nm) between 91 and 97 (257 nm) between 5,0 and 8,0 Refractive index 1,503-1,507 Sulphated ash Not more than 0,1 % Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 309 DELTA-TOCOPHEROL Definition Chemical name 2,8-dimethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol Einecs 204-299-0 Chemical formula C27H46O2 Molecular weight 402,7 Assay Content not less than 97 % Description Clear, viscous, pale yellowish or orange oil which oxidises and darkens on exposure to air or light Identification A. Spectrometry Maximum absorptions in absolute ethanol at about 298 nm and 257 nm Purity Specific absorption in ethanol (298 nm) between 89 and 95 (257 nm) between 3,0 and 6,0 Refractive index 1,500-1,504 Sulphated ash Not more than 0,1 % Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 310 PROPYL GALLATE Definition Chemical name Propyl gallate Propyl ester of gallic acid n-propyl ester of 3,4,5-trihydroxybenzoic acid Einecs 204-498-2 Chemical formula C10H12O5 Molecular weight 212,20 Assay Content not less than 98 % on the anhydrous basis Description White to creamy-white, crystalline, odourless solid Identification A. Solubility tests Slightly soluble in water, freely soluble in ethanol, ether and propane-1,2-diol B. Melting range Between 146 oC and 150 oC after drying at 110 oC for four hours Purity Loss on drying Not more than 1,0 % (110 oC, four hours) Sulphated ash Not more than 0,1 % Free acid Not more than 0,5 % (as gallic acid) Chlorinated organic compound Not more than 100 mg/kg (as C1) Specific absorption in ethanol (275 nm) not less than 485 and not more than 520 Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 311 OCTYL GALLATE Definition Chemical name Octyl gallate Octyl ester of gallic acid n-octyl ester of 3,4,5-trihydroxybenzoic acid Einecs 213-853-0 Chemical formula C15H22O5 Molecular weight 282,34 Assay Content not less than 98 % after drying at 90 oC for six hours Description White to creamy-white odourless solid Identification A. Solubility tests Insoluble in water, freely soluble in ethanol, ether and propane-1,2-diol B. Melting range Between 99 oC and 102 oC after drying at 90 oC for six hours Purity Loss on drying Not more than 0,5 % (90 oC, six hours) Sulphated ash Not more than 0,05 % Free acid Not more than 0,5 % (as gallic acid) Chlorinated organic compound Not more than 100 mg/kg (as C1) Specific absorption in ethanol (275 nm) not less than 375 and not more than 390 Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 312 DODECYL GALLATE Synonyms Lauryl gallate Definition Chemical name Dodecyl gallate n-dodecyl (or lauryl) ester of 3,4,5-trihydroxybenzoic acid Dodecyl ester of gallic acid Einecs 214-620-6 Chemical formula C19H30O5 Molecular weight 338,45 Assay Content not less than 98 % after drying at 90 oC for six hours Description White or creamy-white odourless solid Identification A. Solubility tests Insoluble in water, freely soluble in ethanol and ether B. Melting range Between 95 oC and 98 oC after drying at 90 oC for six hours Purity Loss on drying Not more than 0,5 % (90 oC, six hours) Sulphated ash Not more than 0,05 % Free acid Not more than 0,5 % (as gallic acid) Chlorinated organic compound Not more than 100 mg/kg (as Cl) Specific absorption in ethanol (275 nm) not less than 300 and not more than 325 Arsenic Not more than 3 mg/kg Lead Not more than 10 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 30 mg/kg E 315 ERYTHORBIC ACID Synonyms Isoascorbic acid D-Araboascorbic acid Definition Chemical name D-Erythro-hex-2-enoic acid γ-lactone Isoascorbic acid D-Isoascorbic acid Einecs 201-928-0 Chemical formula C6H8O6 Molecular weight 176,13 Assay Content not less than 98 % on the anhydrous basis Description White to slightly yellow crystalline solid which darkens gradually on exposure to light Identification A. Melting range About 164 oC to 172 oC with decomposition B. Positive test for ascorbic acid/colour reaction Purity Loss on drying Not more than 0,4 % after drying under reduced pressure on silica gel for 3 hours Sulphated ash Not more than 0,3 % Specific rotation [α]10 % (w/v) aqueous solution between -16,5o to -18,0o Oxalate To 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 Lead Not more than 2 mg/kg E 316 SODIUM ERYTHORBATE Synonyms Sodium isoascorbate Definition Chemical name Sodium isoascorbate Sodium D-isoascorbic acid Sodium salt of 2,3-didehydro-D-erythro-hexono-1,4-lactone 3-keto-D-gulofurano-lactone sodium enolate monohydrate Einecs 228-973-9 Chemical formula C6H7O6Na· H2O Molecular weight 216,13 Assay Content not less than 98 % after drying in a vacuum desiccator over sulphuric acid for 24 hours expressed on the monohydrate basis Description White crystalline solid Identification A. Solubility tests Freely soluble in water, very slightly soluble in ethanol B. Positive test for ascorbic acid/colour reaction C. Positive test for sodium Purity Loss on drying Not more than 0,25 % after drying in a vacuum desiccator over sulphuric acid for 24 hours Specific rotation [α]10 % (w/v) aqueous solution between + 95o and + 98o pH of a 10 % aqueous solution 5,5 to 8,0 Oxalate To 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 Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 319 TERTIARY-BUTYLHYDROQUINONE (TBHQ) Synonyms TBHQ Definition Chemical names Tert-butyl-1,4-benzenediol 2-(1,1-Dimethylethyl)-1,4-benzenediol Einecs 217-752-2 Chemical formula C10H14O2 Molecular weight 166,22 Assay Content not less than 99 % of C10H14O2 Description White crystalline solid having a characteristic odour Identification A. Solubility Practically insoluble in water; soluble in ethanol B. Melting point Not less than 126,5 oC C. Phenolics Dissolve about 5 mg of the sample in 10 ml of methanol and add 10,5 ml of dimethylamine solution (1 in 4). A red to pink colour is produced Purity Tertiary-Butyl-p-benzoquinone Not more than 0,2 % 2,5-Di-tertiary-butyl hydroquinone Not more than 0,2 % Hydroxyquinone Not more than 0,1 % Toluene Not more than 25 mg/kg Lead Not more than 2 mg/kg E 320 BUTYLATED HYDROXYANISOLE (BHA) Synonyms BHA Definition Chemical names 3-Tertiary-butyl-4-hydroxyanisole A mixture of 2-tertiary-butyl-4-hydroxyanisole and 3-tertiary-butyl-4-hydroxyanisole Einecs 246-563-8 Chemical formula C11H16O2 Formula weight 180,25 Assay Content not less than 98,5 % of C11H16O2 and not less than 85 % of 3-tertiary-butyl-4-hydroxyanisole isomer Description White or slightly yellow crystals or waxy solid with a slight aromatic smell Identification A. Solubility Insoluble in water, freely soluble in ethanol B. Melting range Between 48 °C and 63 °C C. Colour reaction Passes test for phenol groups Purity Sulphated ash Not more than 0,05 % after calcination at 800 ± 25 °C Phenolic impurities Not more than 0,5 % Specific absorption (290 nm) not less than 190 and not more than 210 Specific absorption (228 nm) not less than 326 and not more than 345 Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg E 321 BUTYLATED HYDROXYTOLUENE (BHT) Synonyms BHT Definition Chemical name 2,6-Ditertiary-butyl-p-cresol 4-Methyl-2,6-ditertiarybutylphenol Einecs 204-881-4 Chemical formula C15H24O Molecular weight 220,36 Assay Content not less than 99 % Description White, crystalline or flaked solid, odourless or having a characteristic faint aromatic odour Identification A. Solubility tests Insoluble in water and propane- 1,2-diol Freely soluble in ethanol B. Melting point At 70 oC C. Absorbance maximum The absorption in the range 230 to 320 nm of a 2 cm layer of a 1 in 100 000 solution in dehydrated ethanol exhibits a maximum only at 278 nm Purity Sulphated ash Not more than 0,005 % Phenolic impurities Not more than 0,5 % Specific absorption in ethanol (278 nm) not less than 81 and not more than 88 Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 322 LECITHINS Synonyms Phosphatides Phospholipids Definition Lecithins 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 activity The lecithins may be slightly bleached in aqueous medium by means of hydrogen peroxide. This oxidation must not chemically modify the lecithin phosphatides Einecs 232-307-2 Assay — Lecithins: not less than 60,0 % of substances insoluble in acetone — Hydrolysed lecithins: not less than 56,0 % of substances insoluble in acetone Description — Lecithins: brown liquid or viscous semi-liquid or powder — Hydrolysed lecithins: light brown to brown viscous liquid or paste Identification A. Positive tests for choline, for phosphorus and fatty acids B. Test for hydrolysed lecithin To a 800 ml beaker add 500 ml of water (30 oC-35 oC). 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 Purity Loss on drying Not more than 2,0 % determined by drying at 105 oC for one hour Toluene-insoluble matter Not more than 0,3 % Acid value — Lecithins: not more than 35 mg of potassium hydroxide per gram — Hydrolysed lecithins: not more than 45 mg of potassium hydroxide per gram Peroxide value Equal to or less than 10 Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 325 SODIUM LACTATE Definition Chemical name Sodium lactate Sodium 2-hydroxypropanoate Einecs 200-772-0 Chemical formula C3H5NaO3 Molecular weight 112,06 (anhydrous) Assay Content not less than 57 % and not more than 66 % Description Colourless, transparent, liquid. Odourless, or with a slight, characteristic odour Identification A. Positive test for lactate B. Positive test for sodium Purity Acidity Not more than 0,5 % after drying expressed as lactic acid pH of a 20 % aqueous solution 6,5 to 7,5 Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg Reducing substances No reduction of Fehling's solution Note: This specification refers to a 60 % aqueous solution E 326 POTASSIUM LACTATE Definition Cheminal name Potassium lactate Potassium 2-hydroxypropanoate Einecs 213-631-3 Chemical formula C3H5O3K Molecular weight 128,17 (anhydrous) Assay Content not less than 57 % and not more than 66 % Description Slightly viscous, almost odourless clear liquid. Odourless, or with a slight, characteristic odour Identification A. Ignition Ignite potassium lactate solution to an ash. The ash is alkaline, and an effervescence occurs when acid is added B. Colour reaction Overlay 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 Purity Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg Acidity Dissolve 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 substances Potassium lactate solution shall not cause any reduction of Fehling's solution Note: This specification refers to a 60 % aqueous solution E 327 CALCIUM LACTATE Definition Chemical name Calcium dilactate Calcium dilactate hydrate 2-Hydroxypropanoic acid calcium salt Einecs 212-406-7 Chemical formula (C3H5O2)2 Ca· nH2O (n = 0-5) Molecular weight 218,22 (anhydrous) Assay Content not less than 98 % on the anhydrous basis Description Almost odourless, white crystalline powder or granules Identification A. Positive tests for lactate and for calcium B. Solubility tests Soluble in water and practically insoluble in ethanol Purity Loss on drying Determined by drying at 120 oC 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 % Acidity Not more than 0,5 % of the dry matter expressed as lactic acid Fluoride Not more than 30 mg/kg (expressed as fluorine) pH of a 5 % solution Between 6,0 and 8,0 Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg Reducing substances No reduction of Fehling's solution E 330 CITRIC ACID Definition Chemical name Citric acid 2-Hydroxy-1,2,3-propanetricarboxylic acid β-Hydroxytricarballytic acid Einecs 201-069-1 Chemical formula (a) C6H8O7 (anhydrous) (b) C6H8O7·H2O (monohydrate) Molecular weight (a) 192,13 (anhydrous) (b) 210,15 (monohydrate) Assay Citric 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 Description Citric acid is a white or colourless, odourless, crystalline solid, having a strongly acid taste. The monohydrate effloresces in dry air Identification A. Solubility tests Very soluble in water; freely soluble in ethanol; soluble in ether Purity Water content Anhydrous citric acid contains not more than 0,5 % water; citric acid monohydrate contains not more than 8,8 % water (Karl Fischer method) Sulphated ash Not more than 0,05 % after calcination at 800 ± 25 oC Arsenic Not more than 1 mg/kg Lead Not more than 1 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 5 mg/kg Oxalates Not more than 100 mg/kg, expressed as oxalic acid, after drying Readily carbonisable substances Heat 1 g of powdered sample with 10 ml of 98 % minimum sulphuric acid in a water bath at 90 oC in the dark for one hour. Not more than a pale brown colour should be produced (Matching Fluid K) E 331 (i) MONOSODIUM CITRATE Synonyms Monosodium citrate Monobasic sodium citrate Definition Chemical name Monosodium citrate Monosodium 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) Assay Content not less than 99 % on the anhydrous basis Description Crystalline white powder or colourless crystals Identification A. Positive tests for citrate and for sodium Purity Loss on drying Determined by drying at 180 oC for four hours: — anhydrous: not more than 1,0 % — monohydrate: not more than 8,8 % Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying pH of a 1 % aqueous solution Between 3,5 and 3,8 Arsenic Not more than 1 mg/kg Lead Not more than 1 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 5 mg/kg E 331 (ii) DISODIUM CITRATE Synonyms Disodium citrate Dibasic sodium citrate Definition Chemical name Disodium citrate Disodium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid Disodium salt of citric acid with 1,5 molecules of water Einecs 205-623-3 Chemical formula C6H6O7Na2·1,5H2O Molecular weight 263,11 Assay Content not less than 99 % on the anhydrous basis Description Crystalline white powder or colourless crystals Identification A. Positive tests for citrate and for sodium Purity Loss on drying Not more than 13,0 % by drying at 180 oC for four hours Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying pH of a 1 % aqueous solution Between 4,9 and 5,2 Arsenic Not more than 1 mg/kg Lead Not more than 1 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 5 mg/kg E 331 (iii) TRISODIUM CITRATE Synonyms Trisodium citrate Tribasic sodium citrate Definition Chemical name Trisodium citrate Trisodium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid Trisodium salt of citric acid, in anhydrous, dihydrate or pentahydrate form Einecs 200-675-3 Chemical formula Anhydrous: C6H5O7Na3 Hydrated: C6H5O7Na3·nH2O (n = 2 or 5) Molecular weight 258,07 (anhydrous) Assay Not less than 99 % on the anhydrous basis Description Crystalline white powder or colourless crystals Identification A. Positive tests for citrate and for sodium Purity Loss on drying Determined by drying at 180 oC for four hours: — anhydrous: not more than 1,0 % — dihydrate: not more than 13,5 % — pentahydrate: not more than 30,3 % Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying pH of a 5 % aqueous solution Between 7,5 and 9,0 Arsenic Not more than 1 mg/kg Lead Not more than 1 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 5 mg/kg E 332 (i) MONOPOTASSIUM CITRATE Synonyms Monopotassium citrate Monobasic potassium citrate Definition Chemical name Monopotassium citrate Monopotassium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid Anhydrous monopotassium salt of citric acid Einecs 212-753-4 Chemical formula C6H7O7K Molecular weight 230,21 Assay Content not less than 99 % on the anhydrous basis Description White, hygroscopic, granular powder or transparent crystals Identification A. Positive tests for citrate and for potassium Purity Loss on drying Not more than 1,0 % determined by drying at 180 oC for four hours Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying pH of a 1 % aqueous solution Between 3,5 and 3,8 Arsenic Not more than 1 mg/kg Lead Not more than 1 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 5 mg/kg E 332 (ii) TRIPOTASSIUM CITRATE Synonyms Tripotassium citrate Tribasic potassium citrate Definition Chemical name Tripotassium citrate Tripotassium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid Monohydrated tripotassium salt of citric acid Einecs 212-755-5 Chemical formula C6H5O7K3·H2O Molecular weight 324,42 Assay Content not less than 99 % on the anhydrous basis Description White, hygroscopic, granular powder or transparent crystals Identification A. Positive tests for citrate and for potassium Purity Loss on drying Not more than 6,0 % determined by drying at 180 oC for four hours Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying pH of a 5 % aqueous solution Between 7,5 and 9,0 Arsenic Not more than 1 mg/kg Lead Not more than 1 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 5 mg/kg E 333 (i) MONOCALCIUM CITRATE Synonyms Monocalcium citrate Monobasic calcium citrate Definition Chemical name Monocalcium citrate Monocalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid Monohydrate monocalcium salt of citric acid Chemical formula (C6H7O7)2Ca· H2O Molecular weight 440,32 Assay Content not less than 97,5 % on the anhydrous basis Description Fine white powder Identification A. Positive tests for citrate and for calcium Purity Loss on drying Not more than 7,0 % determined by drying at 180 oC for four hours Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying pH of a 1 % aqueous solution Between 3,2 and 3,5 Fluoride Not more than 30 mg/kg (expressed as fluorine) Arsenic Not more than 1 mg/kg Lead Not more than 1 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 5 mg/kg Carbonates Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must not liberate more than a few isolated bubbles E 333 (ii) DICALCIUM CITRATE Synonyms Dicalcium citrate Dibasic calcium citrate Definition Chemical name Dicalcium citrate Dicalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid Trihydrated dicalcium salt of citric acid Chemical formula (C6H7O7)2Ca2·3H2O Molecular weight 530,42 Assay Not less than 97,5 % on the anhydrous basis Description Fine white powder Identification A. Positive tests for citrate and for calcium Purity Loss on drying Not more than 20,0 % determined by drying at 180 oC for four hours Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying Fluoride Not more than 30 mg/kg (expressed as fluorine) Arsenic Not more than 1 mg/kg Lead Not more than 1 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 5 mg/kg Carbonates Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must not liberate more than a few isolated bubbles E 333 (iii) TRICALCIUM CITRATE Synonyms Tricalcium citrate Tribasic calcium citrate Definition Chemical name Tricalcium citrate Tricalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid Tetrahydrated tricalcium salt of citric acid Einecs 212-391-7 Chemical formula (C6H6O7)2Ca3·4H2O Molecular weight 570,51 Assay Not less than 97,5 % on the anhydrous basis Description Fine white powder Identification A. Positive tests for citrate and for calcium Purity Loss on drying Not more than 14,0 % determined by drying at 180 oC for four hours Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying Fluoride Not more than 30 mg/kg (expressed as fluorine) Arsenic Not more than 1 mg/kg Lead Not more than 1 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 5 mg/kg Carbonates Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must not liberate more than a few isolated bubbles E 334 L(+)-TARTARIC ACID Definition Chemical name L-tartaric acid L-2,3-dihydroxybutanedioic acid d-α, β-dihydroxysuccinic acid Einecs 201-766-0 Chemical formula C4H6O6 Molecular weight 150,09 Assay Content not less than 99,5 % on the anhydrous basis Description Colourless or translucent crystalline solid or white crystalline powder Identification A. Melting range Between 168 oC and 170 oC B. Positive test for tartrate Purity Loss on drying Not more than 0,5 % (over P2O5, three hours) Sulphated ash Not more than 1 000 mg/kg after calcination at 800 ± 25 oC Specific optical rotation of a 20 % w/v aqueous solution [α] 20 D between +11,5o and +13,5o Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying E 335 (i) MONOSODIUM TARTRATE Synonyms Monosodium salt of L-(+)-tartaric acid Definition Chemical name Monosodium salt of L-2,3-dihydroxybutanedioic acid Monohydrated monosodium salt of L-(+)-tartaric acid Chemical formula C4H5O6Na· H2O Molecular weight 194,05 Assay Content not less than 99 % on the anhydrous basis Description Transparent colourless crystals Identification A. Positive tests for tartrate and for sodium Purity Loss on drying Not more than 10,0 % determined by drying at 105 oC for four hours Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 335 (ii) DISODIUM TARTRATE Definition Chemical name Disodium L-tartrate Disodium (+)-tartrate Disodium (+)-2,3-dihydroxybutanedioic acid Dihydrated disodium salt of L-(+)-tartaric acid Einecs 212-773-3 Chemical formula C4H4O6Na2·2H2O Molecular weight 230,8 Assay Content not less than 99 % on the anhydrous basis Description Transparent, colourless crystals Identification A. Positive tests for tartrate and for sodium B. Solubility tests 1 gram is insoluble in 3 ml of water. Insoluble in ethanol Purity Loss on drying Not more than 17,0 % determined by drying at 150 oC for four hours Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying pH of a 1 % aqueous solution Between 7,0 and 7,5 Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 336 (i) MONOPOTASSIUM TARTRATE Synonyms Monobasic potassium tartrate Definition Chemical name Anhydrous monopotassium salt of L-(+)-tartaric acid Monopotassium salt of L-2,3-dihydroxybutanedioic acid Chemical formula C4H5O6K Molecular weight 188,16 Assay Content not less than 98 % on the anhydrous basis Description White crystalline or granulated powder Identification A. Positive tests for tartrate and for potassium B. Melting point 230 oC Purity pH of a 1 % aqueous solution 3,4 Loss on drying Not more than 1,0 % determined by drying at 105 oC for four hours Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 336 (ii) DIPOTASSIUM TARTRATE Synonyms Dibasic potassium tartrate Definition Chemical name Dipotassium salt of L-2,3-dihydroxybutanedioic acid Dipotassium salt with half a molecule of water of L-(+)-tartaric acid Einecs 213-067-8 Chemical formula C4H4O6K2·1/2H2O Molecular weight 235,2 Assay Content not less than 99 % on the anhydrous basis Description White crystalline or granulated powder Identification A. Positive tests for tartrate and for potassium Purity pH of a 1 % aqueous solution Between 7,0 and 9,0 Loss on drying Not more than 4,0 % determined by drying at 150 oC for four hours Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 337 POTASSIUM SODIUM TARTRATE Synonyms Potassium sodium L-(+)-tartrate Rochelle salt Seignette salt Definition Chemical name Potassium sodium salt of L-2,3-dihydroxybutanedioic acid Potassium sodium L-(+)-tartrate Einecs 206-156-8 Chemical formula C4H4O6KNa· 4H2O Molecular weight 282,23 Assay Content not less than 99 % on the anhydrous basis Description Colourless crystals or white crystalline powder Identification A. Positive tests for tartrate, for potassium and for sodium B. Solubility tests 1 gram is soluble in 1 ml of water, insoluble in ethanol C. Melting range Between 70 and 80 oC Purity Loss on drying Not more than 26,0 % and not less than 21,0 % determined by drying at 150 oC for three hours Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying pH of 1 % aqueous solution Between 6,5 and 8,5 Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 338 PHOSPHORIC ACID Synonyms Orthophosphoric acid Monophosphoric acid Definition Chemical name Phosphoric acid Einecs 231-633-2 Chemical formula H3PO4 Molecular weight 98,00 Assay Phosphoric acid is commercially available as an aqueous solution at variable concentrations. Content not less than 67,0 % and not more than 85,7 %. Description Clear, colourless, viscous liquid Identification A. Positive tests for acid and for phosphate Purity Volatile acids Not more than 10 mg/kg (as acetic acid) Chlorides Not more than 200 mg/kg (expressed as chlorine) Nitrates Not more than 5 mg/kg (as NaNO3) Sulphates Not more than 1 500 mg/kg (as CaSO4) Fluoride Not more than 10 mg/kg (expressed as fluorine) Arsenic Not more than 3 mg/kg Cadmium Not more than 1 mg/kg Lead Not more than 4 mg/kg Mercury Not more than 1 mg/kg Note: This specification refers to a 75 % aqueous solution E 339 (i) MONOSODIUM PHOSPHATE Synonyms Monosodium monophosphate Acid monosodium monophosphate Monosodium orthophosphate Monobasic sodium phosphate Sodium dihydrogen monophosphate Definition Chemical name Sodium dihydrogen monophosphate Einecs 231-449-2 Chemical formula Anhydrous: NaH2PO4 Monohydrate: NaH2PO4 · H2O Dihydrate: NaH2PO4 · 2H2O Molecular weight Anhydrous: 119,98 Monohydrate: 138,00 Dihydrate: 156,01 Assay After drying at 60 oC for one hour and then at 105 oC for four hours, contains not less than 97 % of NaH2PO4 P2O5 content Between 58,0 % and 60,0 % on the anhydrous basis Description A white odourless, slightly deliquescent powder, crystals or granules Identification A. Positive tests for sodium and for phosphate B. Solubility Freely soluble in water. Insoluble in ethanol or ether C. pH of a 1 % solution Between 4,1 and 5,0 Purity Loss on drying The 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 oC for one hour, then at 105 oC for four hours Water-insoluble substances Not more than 0,2 % on the anhydrous basis Fluoride Not more than 10 mg/kg (expressed as fluorine) Arsenic Not more than 3 mg/kg Cadmium Not more than 1 mg/kg Lead Not more than 4 mg/kg Mercury Not more than 1 mg/kg E 339 (ii) DISODIUM PHOSPHATE Synonyms Disodium monophosphate Secondary sodium phosphate Disodium orthophosphate Acid disodium phosphate Definition Chemical name Disodium hydrogen monophosphate Disodium hydrogen orthophosphate Einecs 231-448-7 Chemical formula Anhydrous: Na2HPO4 Hydrat: Na2HPO4 · nH2O (n = 2,7 or 12) Molecular weight 141,98 (anhydrous) Assay After drying at 40 oC for three hours and subsequently at 105 oC for five hours, contains not less than 98 % of Na2HPO4 P2O5 content Between 49 % and 51 % on the anhydrous basis Description Anhydrous 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 Identification A. Positive tests for sodium and for phosphate B. Solubility Freely soluble in water. Insoluble in ethanol C. pH of a 1 % solution Between 8,4 and 9,6 Purity Loss on drying When dried at 40 oC for three hours and then at 105 oC 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 substances Not more than 0,2 % on the anhydrous basis Fluoride Not more than 10 mg/kg (expressed as fluorine) Arsenic Not more than 3 mg/kg Cadmium Not more than 1 mg/kg Lead Not more than 4 mg/kg Mercury Not more than 1 mg/kg E 339 (iii) TRISODIUM PHOSPHATE Synonyms Sodium phosphate Tribasic sodium phosphate Trisodium orthophosphate Definition Trisodium 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 1/4 molecule of NaOH Chemical name Trisodium monophosphate Trisodium phosphate Trisodium orthophosphate Einecs 231-509-8 Chemical formula Anhydrous: Na3PO4 Hydrated: Na3PO4 · nH2O (n = 1/2, 1, 6, 8, or 12) Molecular weight 163,94 (anhydrous) Assay Sodium 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 content Between 40,5 % and 43,5 % on the anhydrous basis Description White odourless crystals, granules or crystalline powder Identification A. Positive tests for sodium and for phosphate B. Solubility Freely soluble in water. Insoluble in ethanol C. pH of a 1 % solution Between 11,5 and 12,5 Purity Loss on ignition When dried at 120 oC for two hours and then ignited at about 800 oC 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 substances Not more than 0,2 % on the anhydrous basis Fluoride Not more than 10 mg/kg (expressed as fluorine) Arsenic Not more than 3 mg/kg Cadmium Not more than 1 mg/kg Lead Not more than 4 mg/kg Mercury Not more than 1 mg/kg E 340 (i) MONOPOTASSIUM PHOSPHATE Synonyms Monobasic potassium phosphate Monopotassium monophosphate Potassium orthophosphate Definition Chemical name Potassium dihydrogen phosphate Monopotassium dihydrogen orthophosphate Monopotassium dihydrogen monophosphate Einecs 231-913-4 Chemical formula KH2PO4 Molecular weight 136,09 Assay Content not less than 98,0 % after drying at 105 oC for four hours P2O5 content Between 51,0 % and 53,0 % on the anhydrous basis Description Odourless, colourless crystals or white granular or crystalline powder, hygroscopic Identification A. Positive tests for potassium and for phosphate B. Solubility Freely soluble in water. Insoluble in ethanol C. pH of a 1 % solution Between 4,2 and 4,8 Purity Loss on drying Not more than 2,0 % determined by drying at 105 oC for four hours Water-insoluble substances Not more than 0,2 % on the anhydrous basis Fluoride Not more than 10 mg/kg (expressed as fluorine) Arsenic Not more than 3 mg/kg Cadmium Not more than 1 mg/kg Lead Not more than 4 mg/kg Mercury Not more than 1 mg/kg E 340 (ii) DIPOTASSIUM PHOSPHATE Synonyms Dipotassium monophosphate Secondary potassium phosphate Dipotassium acid phosphate Dipotassium orthophosphate Dibasic potassium phosphate Definition Chemical name Dipotassium hydrogen monophosphate Dipotassium hydrogen phosphate Dipotassium hydrogen orthophosphate Einecs 231-834-5 Chemical formula K2HPO4 Molecular weight 174,18 Assay Content not less than 98 % after drying at 105 oC for four hours P2O5 content Between 40,3 % and 41,5 % on the anhydrous basis Description Colourless or white granular powder, crystals or masses; deliquescent substance Identification A. Positive tests for potassium and for phosphate B. Solubility Freely soluble in water. Insoluble in ethanol C. pH of a 1 % solution Between 8,7 and 9,4 Purity Loss on drying Not more than 2,0 % determined by drying at 105 oC for four hours Water-insoluble substances Not more than 0,2 % on the anhydrous basis Fluoride Not more than 10 mg/kg (expressed as fluorine) Arsenic Not more than 3 mg/kg Cadmium Not more than 1 mg/kg Lead Not more than 4 mg/kg Mercury Not more than 1 mg/kg E 340 (iii) TRIPOTASSIUM PHOSPHATE Synonyms Potassium phosphate Tribasic potassium phosphate Tripotassium orthophosphate Definition Chemical name Tripotassium monophosphate Tripotassium phosphate Tripotassium orthophosphate Einecs 231-907-1 Chemical formula Anhydrous: K3PO4 Hydrated: K3PO4 · nH2O (n = 1 or 3) Molecular weight 212,27 (anhydrous) Assay Content not less than 97 % calculated on the ignited basis P2O5 content Between 30,5 % and 33,0 % on the ignited basis Description Colourless or white, odourless hygroscopic crystals or granules. Hydrated forms available include the monohydrate and trihydrate Identification A. Positive tests for potassium and for phosphate B. Solubility Freely soluble in water. Insoluble in ethanol C. pH of a 1 % solution Between 11,5 and 12,3 Purity Loss on ignition Anhydrous: not more than 3,0 %; hydrated: not more than 23,0 %. Determined by drying at 105 oC for one hour and then ignite at about 800 oC ± 25 oC for 30 minutes Water insoluble substances Not more than 0,2 % on the anhydrous basis Fluoride Not more than 10 mg/kg (expressed as fluorine) Arsenic Not more than 3 mg/kg Cadmium Not more than 1 mg/kg Lead Not more than 4 mg/kg Mercury Not more than 1 mg/kg E 341 (i) MONOCALCIUM PHOSPHATE Synonyms Monobasic calcium phosphate Monocalcium orthophosphate Definition Chemical name Calcium dihydrogen phosphate Einecs 231-837-1 Chemical formula Anhydrous: Ca(H2PO4)2 Monohydrate: Ca(H2PO4)2 · H2O Molecular weight 234,05 (anhydrous) 252,08 (monohydrate) Assay Content not less than 95 % on the dried basis P2O5 content Between 55,5 % and 61,1 % on the anhydrous basis Description Granular powder or white, deliquescent crystals or granules Identification A. Positive tests for calcium and for phosphate B. CaO content Between 23,0 % and 27,5 % (anhydrous) Between 19,0 % and 24,8 % (monohydrate) Purity Loss on drying Not more than 14 % determined by drying at 105 oC for four hours (anhydrous) Not more than 17,5 % determined by drying at 60 oC for one hour, then at 105 oC for four hours (monohydrate) Loss on ignition Not more than 17,5 % after ignition at 800 oC ± 25 oC for 30 minutes (anhydrous) Not more than 25,0 % determined by drying at 105 oC for one hour, then ignite at 800 oC ± 25 oC for 30 minutes (monohydrate) Fluoride Not more than 30 mg/kg (expressed as fluorine) Arsenic Not more than 3 mg/kg Cadmium Not more than 1 mg/kg Lead Not more than 4 mg/kg Mercury Not more than 1 mg/kg E 341 (ii) DICALCIUM PHOSPHATE Synonyms Dibasic calcium phosphate Dicalcium orthophosphate Definition Chemical name Calcium monohydrogen phosphate Calcium hydrogen orthophosphate Secondary calcium phosphate Einecs 231-826-1 Chemical formula Anhydrous: CaHPO4 Dihydrate: CaHPO4 · 2H2O Molecular weight 136,06 (anhydrous) 172,09 (dihydrate) Assay Dicalcium phosphate, after drying at 200 oC for three hours, contains not less than 98 % and not more than the equivalent of 102 % of CaHPO4 P2O5 content Between 50,0 % and 52,5 % on the anhydrous basis Description White crystals or granules, granular powder or powder Identification A. Positive tests for calcium and for phosphate B. Solubility tests Sparingly soluble in water. Insoluble in ethanol Purity Loss on ignition Not more than 8,5 % (anhydrous), or 26,5 % (dihydrate) after ignition at 800 oC ± 25 oC for 30 minutes Fluoride Not more than 50 mg/kg (expressed as fluorine) Arsenic Not more than 3 mg/kg Cadmium Not more than 1 mg/kg Lead Not more than 4 mg/kg Mercury Not more than 1 mg/kg E 341 (iii) TRICALCIUM PHOSPHATE Synonyms Calcium phosphate, tribasic Calcium orthophosphate Pentacalcium hydroxy monophosphate Calcium hydroxyapatite Definition Tricalcium 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 name Pentacalcium hydroxy monophosphate Tricalcium monophosphate Einecs 235-330-6 (Pentacalcium hydroxy monophosphate) 231-840-8 (Calcium orthophosphate) Chemical formula Ca5(PO4)3· OH or Ca3(PO4)2 Molecular weight 502 or 310 Assay Content not less than 90 % calculated on the ignited basis P2O5 content Between 38,5 % and 48,0 % on the anhydrous basis Description A white, odourless powder which is stable in air Identification A. Positive tests for calcium and for phosphate B. Solubility Practically insoluble in water; insoluble in ethanol soluble in dilute hydrochloric and nitric acid Purity Loss on ignition Not more than 8 % after ignition at 800 oC ± 25 oC, to constant weight Fluoride Not more than 50 mg/kg (expressed as fluorine) Arsenic Not more than 3 mg/kg Cadmium Not more than 1 mg/kg Lead Not more than 4 mg/kg Mercury Not more than 1 mg/kg E 343(i) MONOMAGNESIUM PHOSPHATE Synonyms Magnesiumdihydrogenphosphate Magnesiumphosphate, monobasic Monomagnesium orthophosphate Definition Chemical name Monomagnesiumdihydrogenmonophosphate Einecs 236-004-6 Chemical formula Mg(H2PO4)2 · nH2O (where n = 0 to 4) Molecular weight 218,30 (anhydrous) Assay Not less than 51,0 % after ignition Description White, odourless, crystalline powder, slightly soluble in water Identification A. Positive test for magnesium and for phosphate B. MgO content Not less than 21,5 % after ignition Purity Fluoride Not more than 10 mg/kg (as fluorine) Arsenic Not more than 3 mg/kg Lead Not more than 4 mg/kg Cadmium Not more than 1 mg/kg Mercury Not more than 1 mg/kg E 343(ii) DIMAGNESIUM PHOSPHATE Synonyms Magnesiumhydrogenphosphate Magnesiumphosphate, dibasic Dimagnesium orthophosphate Secondary magnesiumphosphate Definition Chemical name Dimagnesiummonohydrogenmonophosphate Einecs 231-823-5 Chemical formula MgHPO4 · nH2O (where n = 0-3) Molecular weight 120,30 (anhydrous) Assay Not less than 96 % after ignition Description White, odourless, crystalline powder, slightly soluble in water Identification A. Positive test for magnesium and for phosphate B. MgO content: Not less than 33,0 % calculated on an anhydrous basis Purity Fluoride Not more than 10 mg/kg (as fluorine) Arsenic Not more than 3 mg/kg Lead Not more than 4 mg/kg Cadmium Not more than 1 mg/kg Mercury Not more than 1 mg/kg E 350 (i) SODIUM MALATE Synonyms Sodium salt of malic acid Definition Chemical name Disodium DL-malate, disodium salt of hydroxybutanedioic acid Chemical formula Hemihydrate: C4H4Na2O5 · 1/2 H2O Trihydrate: C4H4Na2O5 · 3H2O Molecular weight Hemihydrate: 187,05 Trihydrate: 232,10 Assay Content not less than 98,0 % on the anhydrous basis Description White crystalline powder or lumps Identification A. Positive tests for 1,2-dicarboxylic acid and for sodium B. Azo dye formation Positive C. Solubility Freely soluble in water Purity Loss on drying Not more than 7,0 % (130 oC, 4h) for the hemihydrate, or 20,5 %-23,5 % (130 oC, 4h) for the trihydrate Alkalinity Not more than 0,2 % as Na2CO3 Fumaric acid Not more than 1,0 % Maleic acid Not more than 0,05 % Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg E 350 (ii) SODIUM HYDROGEN MALATE Synonyms Monosodium salt of DL-malic acid Definition Chemical name Monosodium DL-malate, monosodium 2-DL-hydroxy succinate Chemical formula C4H5NaO5 Molecular weight 156,07 Assay Content not less than 99,0 % on the anhydrous basis Description White powder Identification A. Positive tests for 1,2-dicarboxylic acid and for sodium B. Azo dye formation Positive Purity Loss on drying Not more than 2,0 % (110 oC, 3h) Maleic acid Not more than 0,05 % Fumaric acid Not more than 1,0 % Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg E 351 POTASSIUM MALATE Synonyms Potassium salt of malic acid Definition Chemical name Dipotassium DL-malate, dipotassium salt of hydroxybutanedioic acid Chemical formula C4H4K2O5 Molecular weight 210,27 Assay Content not less than 59,5 % Description Colourless or almost colourless aqueous solution Identification A. Positive tests for 1,2-dicarboxylic acid and for potassium B. Azo dye formation Positive Purity Alkalinity Not more than 0,2 % as K2CO3 Fumaric acid Not more than 1,0 % Maleic acid Not more than 0,05 % Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg E 352 (i) CALCIUM MALATE Synonyms Calcium salt of malic acid Definition Chemical name Calcium DL-malate, calcium-α-hydroxysuccinate, calcium salt of hydroxybutanedioic acid Chemical formula C4H5CaO5 Molecular weight 172,14 Assay Content not less than 97,5 % on the anhydrous basis Description White powder Identification A. Positive tests for malate, 1,2-dicarboxylic acid and for calcium B. Azo dye formation Positive C. Solubility Slightly soluble in water Purity Loss on drying Not more than 2 % (100 oC, 3h) Alkalinity Not more than 0,2 % as CaCO3 Maleic acid Not more than 0,05 % Fumaric acid Not more than 1,0 % Fluoride Not more than 30 mg/kg Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg E 352 (ii) CALCIUM HYDROGEN MALATE Synonyms Monocalcium salt of DL-malic acid Definition Chemical name Monocalcium DL-malate, monocalcium 2-DL-hydroxysuccinate Chemical formula (C4H5O5)2Ca Assay Content not less than 97,5 % on the anhydrous basis Description White powder Identification A. Positive tests for 1,2-dicarboxylic acid and for calcium B. Azo dye formation Positive Purity Loss on drying Not more than 2,0 % (110 oC, 3h) Maleic acid Not more than 0,05 % Fumaric acid Not more than 1,0 % Fluoride Not more than 30 mg/kg Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg E 353 METATARTARIC ACID Synonyms Ditartaric acid Definition Chemical name Metatartaric acid Chemical formula C4H6O6 Assay Not less than 99,5 % Description Crystalline or powder form with a white or yellowish colour. Very deliquescent with a faint odour of caramel Identification 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 oC, an intense violet coloration appears Purity Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg E 354 CALCIUM TARTRATE Synonyms L-Calcium tartrate Definition Chemical name Calcium L(+)-2,3-dihydroxybutanedioate di-hydrate Chemical formula C4H4CaO6 · 2H2O Molecular weight 224,18 Assay Not less than 98,0 % Description Fine crystalline powder with a white or off-white colour Identification A. Slightly soluble in water. Solubility approximately 0,01 g/100 ml water (20 oC). Sparingly soluble in ethanol. Slightly soluble in diethyl ether. Soluble in acids B. Specific rotation [α]20 D +7,0o to +7,4o (0,1 % in a 1N de HCl solution) C. pH of a 5 % slurry Between 6,0 and 9,0 Purity Sulphates (as H2SO4) Not more than 1 g/kg Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg E 355 ADIPIC ACID Definition Chemical name Hexanedioic acid, 1,4-butanedicarboxylic acid Einecs 204-673-3 Chemical formula C6H10O4 Molecular weight 146,14 Assay Content not less than 99,6 % Description White odourless crystals or crystalline powder Identification A. Melting range 151,5 oC-154,0 oC B. Solubility Slightly soluble in water. Freely soluble in ethanol Purity Water Not more than 0,2 % (Karl Fischer method) Sulphated ash Not more than 20 mg/kg Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg E 356 SODIUM ADIPATE Definition Chemical name Sodium adipate Einecs 231-293-5 Chemical formula C6H8Na2O4 Molecular weight 190,11 Assay Content not less than 99,0 % (on anhydrous basis) Description White odourless crystals or crystalline powder Identification A. Melting range 151 oC-152 oC (for adipic acid) B. Solubility Approximately 50 g/100 ml water (20 oC) C. Positive test for sodium Purity Water Not more than 3 % (Karl Fischer) Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg E 357 POTASSIUM ADIPATE Definition Chemical name Potassium adipate Einecs 242-838-1 Chemical formula C6H8K2O4 Molecular weight 222,32 Assay Content not less than 99,0 % (on anhydrous basis) Description White odourless crystals or crystalline powder Identification A. Melting range 151 oC-152 oC (for adipic acid) B. Solubility Approximately 60 g/100 ml water (20 oC) C. Positive test for potassium Purity Water Not more than 3 % (Karl Fischer) Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg E 363 SUCCINIC ACID Definition Chemical name Butanedioic acid Einecs 203-740-4 Chemical formula C4H6O4 Molecular weight 118,09 Assay Content no less than 99,0 % Description Colourless or white, odourless crystals Identification A. Melting range Between 185,0 oC and 190,0 oC Purity Residue on ignition Not more than 0,025 % (800 oC, 15 min) Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg E 380 TRIAMMONIUM CITRATE Synonyms Tribasic ammonium citrate Definition Chemical name Triammonium salt of 2-hydroxypropan-1,2,3-tricarboxylic acid Einecs 222-394-5 Chemical formula C6H17N3O7 Molecular weight 243,22 Assay Content not less than 97,0 % Description White to off-white crystals or powder Identification A. Positive tests for ammonium and for citrate B. Solubility Freely soluble in water Purity Oxalate Not more than 0,04 % (as oxalic acid