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 °C

Identification

A. Melting range Between 133 °C and 135 °C, 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 °C

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 °C

Identification

A. Melting range of sorbic acid isolated by acidification and not recrystallized 133 °C to 135 °C after vacuum drying in a sulphuric acid desiccator

B. Positive tests for potassium and for double bonds

Purity

Loss on drying Not more than 1,0 % (105 °C, 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 °C for 90 minutes

Identification

A. Melting range of sorbic acid isolated by acidification and not recrystallized 133 °C to 135 °C after vacuum drying in a sulphuric acid desiccator

B. Positive tests for calcium and for double bonds

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 °C to 123,5 °C

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 oxidizable 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 carbonizable 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 (1), 0,3 ml of ferric chloride TSC (2), 0,1 ml of copper sulphate TSC (3) and 4,4 ml of water

Polycyclic acids On fractional acidification of a neutralized solution of benzoic acid, the first precipitate must not have a different melting point from that of the benzoic acid

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 °C 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 recrystallized 121,5 °C to 123,5 °C, 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 °C for four hours

Readily oxidizable 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 (neutralized) 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 Neutralization 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 % C7H5O2K after drying at 105 °C to constant weight

Description White crystalline powder

Identification

A. Melting range of benzoic acid isolated by acidification and not recrystallized 121,5 °C to 123,5 °C, after vacuum drying in a sulphuric acid desiccator

B. Positive tests for benzoate and for potassium

Purity

Loss on drying Not more than 26,5 %, determined by drying at 105 °C

Chlorinated organic compounds Not more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monochlorobenzoic acid

Readily oxidizable 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 carbonizable 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 (neutralized) solution of potassium benzoate, the first precipitate must not have a different melting range from that of benzoic acid

Degree of acidity or alkalinity Neutralization 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 °C

Description White or colourless crystals, or white powder

Identification

A. Melting range of benzoic acid isolated by acidification and not recrystallized 121,5 °C to 123,5 °C, after vacuum drying in a sulphuric acid desiccator

B. Positive tests for benzoate and for calcium

Purity

Loss on drying Not more than 17,5 % determined by drying at 105 °C 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 oxidizable 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 carbonizable 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 (neutralized) solution of calcium benzoate, the first precipitate must not be a different melting range from that of benzoic acid

Degree of acidity or alkalinity Neutralization 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 °C

Description Almost odourless, small, colourless crystals or a white, crystalline powder

Identification

A. Melting range 115 °C to 118 °C

B. Positive test for p-hydroxybenzoate Melting range of p-hydroxybenzoic acid isolated by acidification and not recrystallized: 213 °C to 217 °C, after vacuum drying in a sulphuric acid desiccator

C. Positive test for alcohol

Purity

Loss on drying Not more than 0,5 % after drying for two hours at 80 °C

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 °C to 118 °C, 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 °C to 217 °C

C. Positive test for sodium

D. pH of a 0,1 % aqueous solution must be between 9,9 and 10,3

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 °C

Description Almost odourless, small colourless crystals or white crystalline powder

Identification

A. Melting range 125 °C to 128 °C

B. Positive test for p-hydroxybenzoate Melting range of p-hydroxybenzoic acid derived from the sample is 213 °C to 217 °C after drying for two hours at 80 °C

Purity

Loss on drying Not more than 0,5 %, after drying for two hours at 80 °C

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 °C for two hours, have a melting range of 125 °C to 128 °C

B. Positive test for sodium

C. pH of a 0,1 % solution in carbon dioxide free water, not less than 9,7 and not more than 10,3

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 °C to 70,5 °C

B. Distillation range It distils completely within a 2,5 °C range between 252,5 °C and 257,5 °C

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 carbonizable 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 °C to 58 °C

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 of o-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 recrystallized derived from the sample 56 °C to 58 °C after drying in a sulphuric acid desiccator

C. pH of a 2 % aqueous solution must be between 11,1 and 11,8

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 1205-725-8

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 °C to 303 °C

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 °C to 103 °C

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 neutralized mixture of 20 parts dimethylformamide and 80 parts of water)

D. Specific rotation = + 250 °to + 295 ° (a 1 % w/v solution in glacial acetic acid, at 20 °C and calculated with reference to the dried material)

Purity

Loss on drying Not more than 8 % (over P2O5, in vacuum at 60 °C 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 °C

Purity

Loss on drying Not more than 0,5 % after drying at 105 °C 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

Einecs 224-859-8

Chemical name Dimethyl dicarbonate Pyrocarbonic acid dimethyl ester

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 Boiling point 17 °C 172 °C with decomposition

C. Density 20 °C 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 (5)

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 (5)

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 not more than 8,3

Purity

Loss on drying Not more than 2 % after drying at 105 °C 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 °C 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 °C 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 °C

Purity

Non-volatile residue Not more than 100 mg/kg

Formic acid, formates and other oxidizable substances Not more than 1 000 mg/kg expressed as formic acid

Readily oxidizable 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 °C for two hours

Formic acid, formates and other oxidizable 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 °C, 4 hours)

Trihydrate: Between 36 and 42 % (120 °C, 4 hours)

Formic acid, formates and other oxidizable 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 oxidizable 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 °C to constant weight, for the monohydrate)

Water insoluble matter Not more than 0,3 %

Formic acid, formates and other oxidizable 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 °C

B. Distillation range 138,5 °C to 142,5 °C

Purity

Non-volatile residue Not more than 0,01 % when dried at 140 °C 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 °C

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 °C

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 °C

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 °C

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 °C

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 °C

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 °C

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 °C and 175 °C 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 pressurized cylinders or bulk storage systems, or in compressed solid blocks of ‘dry ice’. Solid (dry ice) forms usually contain added substances, such as propylene glycol or mineral oil, as binders

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 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 °C and 193 °C 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 between + 20,5 ° and + 21,5 ° (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 between + 103 ° and + 106 ° (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 between + 95 ° and + 97 ° (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 °C and 117 °C

Purity

Loss on drying Not more than 2,0 % after drying in a vacuum oven at 56 °C and 60 °C for one hour

Sulphated ash Not more than 0,1 %

Specific rotation between + 21 °and + 24 ° (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 °C

Purity

Loss on drying Not more than 2,0 % after drying in a vacuum oven at 56 °C to 60 °C 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 not less than + 20 °

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 oxidizes and darkens on exposure to air or light

Identification

A. Solubility tests Insoluble in water, freely soluble in ethanol, miscible in ether

B. Spectrophotometry In absolute ethanol the maximum absorption is about 292 nm

Purity

Refractive index n D 201,503to 1,507

Specific absorption E1 % 1 cm in ethanol E1 % 1 cm (292 nm) 72 to 76 (0,01 g in 200 ml of absolute ethanol)

Sulphated ash Not more than 0,1 %

Specific rotation [α]25 D0° ± 0,05° (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 oxidizes 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 oxidizes 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 °C and 150 °C after drying at 110 °C for four hours

Purity

Loss on drying Not more than 1,0 % (110 °C, 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 °C 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 °C and 102 °C after drying at 90 °C for six hours

Purity

Loss on drying Not more than 0,5 % (90 °C, 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 °C 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 °C and 98 °C after drying at 90 °C for six hours

Purity

Loss on drying Not more than 0,5 % (90 °C, 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 °C to 172 °C 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]25 D10 % (w/v) aqueous solution between – 16,5° to – 18,0°

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

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 10 % (w/v) aqueous solution between + 95 ° and + 98 °

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 °C

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

Formula weight 180,25

Assay Content not less than 98,5 % of 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 °C

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 °C—35 °C). Then slowly add 50 ml of the sample with constant stirring. Hydrolysed lecithin will form a homogeneous emulsion. Non-hydrolysed lecithin will form a distinct mass of about 50 g

Purity

Loss on drying Not more than 2,0 % determined by drying at 105 °C 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 potassium

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 °C for four hours: — anhydrous: not more than 3,0 % — with 1 molecule of water: not more than 8,0 % — with 3 molecules of water: not more than 20,0 % — with 4,5 molecules of water: not more than 27,0 %

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 °C

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 carbonizable substances Heat 1 g of powdered sample with 10 ml of 98 % minimum sulphuric acid in a water bath at 90 °C in the dark for one hour. Not more than a pale brown colour should be produced (Matching Fluid K)

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 °C 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 °C 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 °C 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 °C 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 °C 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 °C 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 °C 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 °C 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 °C and 170 °C

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 °C

Specific optical rotation of a 20 % w/v aqueous solution between + 11,5 ° and + 13,5 °

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 °C 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 °C 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 °C

Purity

pH of a 1 % aqueous solution 3,4

Loss on drying Not more than 1,0 % determined by drying at 105 °C 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·H2O

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 °C 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 °C

Purity

Loss on drying Not more than 26,0 % and not less than 21,0 % determined by drying at 150 °C 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 °C for one hour and then at 105 °C 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 °C for one hour, then at 105 °C 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 °C for three hours and subsequently at 105 °C 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 °C for three hours and then at 105°C for five hours, the losses in weight are as follows: anhydrous not more than 5,0 %, dihydrate not more than 22,0 %, heptahydrate not more than 50,0 %, dodecahydrate not more than 61,0 %

Water-insoluble 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 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 °C for two hours and then ignited at about 800 °C for 30 minutes, the losses in weight are as follows: anhydrous not more than 2,0 %, monohydrate not more than 11,0 %, dodecahydrate: between 45,0 % and 58,0 %

Water insoluble 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 °C 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 °C 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°C 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 °C 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 °C for one hour and then ignite at about 800 °C ± 25 °C 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 °C for four hours (anhydrous) Not more than 17,5 % determined by drying at 60 °C for one hour, then at 105 °C for four hours (monohydrate)

Loss on ignition Not more than 17,5 % after ignition at 800 °C ± 25 °C for 30 minutes (anhydrous) Not more than 25,0 % determined by drying at 105 °C for one hour, then ignite at 800 °C ± 25 °C for 30 minutes (monohydrate)

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 °C 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 °C ± 25 °C 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 etanol, soluble in dilute hydrochloric and nitric acid

Purity

Loss on ignition Not more than 8 % after ignition at 800 °C ± 25 °C, 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 385 CALCIUM DISODIUM ETHYLENEDIAMINETETRAACETATE

Synonyms Calcium disodium EDTA Calcium disodium edetate

Definition

Chemical name N,N′-1,2-Ethanediylbis [N-(carboxymethyl)-glycinate] [(4-)-O,O′,ON,ON]calciate(2)-disodium Calcium disodium ethylenediaminetetra acetate Calcium disodium (ethylenedinitrilo)tetra acetate

Einecs 200-529-9

Chemical formula C10H12O8CaN2Na2·2H2O

Molecular weight 410,31

Assay Content not less than 97 % on the anhydrous basis

Description White, odourless crystalline granules or white to nearly white powder, slightly hygroscopic

Identification

A. Positive tests for sodium and for calcium

B. Chelating activity to metal ions positive

C. pH of a 1 % solution between 6,5 and 7,5

Purity

Water content 5 to 13 % (Karl Fischer method)

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

Ethylene oxide may not be used for sterilising purposes in food additives

E 400 ALGINIC ACID

Definition Linear glycuronoglycan consisting mainly of β-(1-4) linked D-mannuronic and α-(1-4) linked L-guluronic acid units in pyranose ring form. Hydrophilic colloidal carbohydrate extracted by the use of dilute alkali from natural strains of various species of brown seaweeds (Phaeophyceae)

Einecs 232-680-1

Chemical formula (C6H8O6)n

Molecular weight 10 000—600 000 (typical average)

Assay Alginic acid yields, on the anhydrous basis, not less than 20 % and not more than 23 % of carbon dioxide (CO2), equivalent to not less than 91 % and not more than 104,5 % of alginic acid (C6H8O6)n (calculted on equivalent weight basis of 200)

Description Alginic acid occurs in filamentous, grainy, granular and powdered forms. It is a white to yellowish brown and nearly odourless

Identification

A. Solubility Insoluble in water and organic solvents, slowly soluble in solutions of sodium carbonate, sodium hydroxide and trisodium phosphate

B. Calcium chloride precipitation test To a 0,5 % solution of the sample in 1 M sodium hydroxide solution, add one fifth of its volume of a 2,5 % solution of calcium chloride. A voluminous, gelatinous precipitate is formed. This test distinguishes alginic acid from acacia gum, sodium carboxymethyl cellulose, carboxymethyl starch, carrageenan, gelatin, gum ghatti, karaya gum, locust bean gum, methyl cellulose and tragacanth gum

C. Ammonium sulphate precipitation test To a 0,5 % solution of the sample in 1 M sodium hydroxide solution, add one half of its volume of a saturated solution of ammonium sulphate. No precipitate is formed. This test distinguishes alginic acid from agar, sodium carboxymethyl cellulose, carrageenan, de-esterified pectin, gelatin, locust bean gum, methyl cellulose and starch

D. Colour reaction Dissolve as completely as possible 0,01 g of the sample by shaking with 0,15 ml of 0,1 N sodium hydroxide and add 1 ml of acid ferric sulphate solution. Within 5 minutes, a cherry-red colour develops that finally becomes deep purple

Purity

pH of a 3 % suspension Between 2,0 and 3,5

Loss on drying Not more than 15 % (105 °C, 4 hours)

Sulphated ash Not more than 8 % on the anhydrous basis

Sodium hydroxide (1 M solution) Not more than 2 % on the anhydrous basis insoluble matter

Arsenic Not more than 3 mg/kg

Lead Not more than 5 mg/kg

Mercury Not more than 1 mg/kg

Cadmium Not more than 1 mg/kg

Heavy metals (as Pb) Not more than 20 mg/kg

Total plate count Not more than 5 000 colonies per gram

Yeast and moulds Not more than 500 colonies per gram

E. coli Negative in 5 g

Salmonella spp. Negative in 10 g

E 401 SODIUM ALGINATE

Definition

Chemical name Sodium salt of alginic acid

Chemical formula (C6H7NaO6)n

Molecular weight 10 000-600 000 (typical average)

Assay Yields, on the anhydrous basis, not less than 18 % and not more than 21 % of carbon dioxide corresponding to not less than 90,8 % and not more than 106,0 % of sodium alginate (calculated on equivalent weight basis of 222)

Description Nearly odourless, white to yellowish fibrous or granular powder

Identification

A. Positive test for sodium and alginic acid

Purity

Loss on drying Not more than 15 % (105 °C, 4 hours)

Water-insoluble matter Not more than 2 % on the anhydrous basis

Arsenic Not more than 3 mg/kg

Lead Not more than 5 mg/kg

Mercury Not more than 1 mg/kg

Cadmium Not more than 1 mg/kg

Heavy metals (as Pb) Not more than 20 mg/kg

Total plate count Not more than 5 000 colonies per gram

Yeast and moulds Not more than 500 colonies per gram

E. coli Negative in 5 g

Salmonella spp. Negative in 10 g

E 402 POTASSIUM ALGINATE

Definition

Chemical name Potassium salt of alginic acid

Chemical formula (C6H7KO6)n

Molecular weight 10 000-600 000 (typical average)

Assay Yields, on the anhydrous basis, not less than 16,5 % and not more than 19,5 % of carbon dioxide corresponding to not less than 89,2 % and not more than 105,5 % of potassium alginate (calculated on an equivalent weight basis of 238)

Description Nearly odourless, white to yellowish fibrous or granular powder

Identification

A. Positive test for potassium and for alginic acid

Purity

Loss on drying Not more than 15 % (105 °C, 4 hours)

Water-insoluble matter Not more than 2 % on the anhydrous basis

Arsenic Not more than 3 mg/kg

Lead Not more than 5 mg/kg

Mercury Not more than 1 mg/kg

Cadmium Not more than 1 mg/kg

Heavy metals (as Pb) Not more than 20 mg/kg

Total plate count Not more than 5 000 colonies per gram

Yeast and moulds Not more than 500 colonies per gram

E. coli Negative in 5 g

Salmonella spp. Negative in 10 g

E 403 AMMONIUM ALGINATE

Definition

Chemical name Ammonium salt of alginic acid

Chemical formula (C6H11NO6)n

Molecular weight 10 000-600 000 (typical average)

Assay Yields, on the anhydrous basis, not less than 18 % and not more than 21 % of carbon dioxide corresponding to not less than 88,7 % and not more than 103,6 % ammonium alginate (calculated on an equivalent weight basis of 217)

Description White to yellowish fibrous or granular powder

Identification

A. Positive test for ammonium and alginic acid

Purity

Loss on drying Not more than 15 % (105 °C, 4 hours)

Sulphated ash Not more than 7 % on the dried basis

Water-insoluble matter Not more than 2 % on the anhydrous basis

Arsenic Not more than 3 mg/kg

Lead Not more than 5 mg/kg

Mercury Not more than 1 mg/kg

Cadmium Not more than 1 mg/kg

Heavy metals Not more than 20 mg/kg

Total plate count Not more than 5 000 colonies per gram

Yeast and moulds Not more than 500 colonies per gram

E. coli Negative in 5 g

Salmonella spp. Negative in 10 g

E 404 CALCIUM ALGINATE

Synonyms Calcium salt of alginate

Definition

Chemical name Calcium salt of alginic acid

Chemical formula (C6H7Ca1/2O6)n

Molecular weight 10 000-600 000 (typical average)

Assay Yields, on the anhydrous basis, not less than 18 % and not more than 21 % carbon dioxide corresponding to not less than 89,6 % and not more than 104,5 % of calcium alginate (calculated on an equivalent weight basis of 219)

Description Nearly odourless, white to yellowish fibrous or granular powder

Identification

A. Positive test for calcium and alginic acid

Purity

Loss on drying Not more than 15,0 % (105 °C, 4 hours)

Arsenic Not more than 3 mg/kg

Lead Not more than 5 mg/kg

Mercury Not more than 1 mg/kg

Cadmium Not more than 1 mg/kg

Heavy metals (as Pb) Not more than 20 mg/kg

Total plate count Not more than 5 000 colonies per gram

Yeast and moulds Not more than 500 colonies per gram

E. coli Negative in 5 g

Salmonella spp. Negative in 10 g

E 405 PROPANE-1,2-DIOL ALGINATE

Synonyms Hydroxypropyl alginate 1,2-propanediol ester of alginic acid Propylene glycol alginate

Definition

Chemical name Propane-1,2-diol ester of alginic acid; varies in composition according to its degree of esterification and the percentage of free and neutralised carboxyl groups in the molecule

Chemical formula (C9H14O7)n (esterified)

Molecular weight 10 000—600 000 (typical average)

Assay Yields, on the anhydrous basis, not less than 16 % and not more than 20 % of CO2 of carbon dioxide

Description Nearly odourless, white to yellowish brown fibrous or granular powder

Identification

A. Positive test for 1,2-propanediol and alginic acid after hydrolysis

Purity

Loss on drying Not more than 20 % (105 °C, 4 hours)

Total propane-1,2-diol content Not less than 15 % and not more than 45 %

Free propane-1,2-diol content Not more than 15 %

Water-insoluble matter Not more than 2 % on the anhydrous basis

Arsenic Not more than 3 mg/kg

Lead Not more than 5 mg/kg

Mercury Not more than 1 mg/kg

Cadmium Not more than 1 mg/kg

Heavy metals (as Pb) Not more than 20 mg/kg

Total plate count Not more than 5 000 colonies per gram

Yeast and moulds Not more than 500 colonies per gram

E. coli Negative in 5 g

Salmonella spp. Negative in 10 g

E 406 AGAR

Synonyms Gelose Japan agar Bengal, Ceylon, Chinese or Japanese isinglass Layor Carang

Definition

Chemical name Agar is a hydrophilic colloidal polysaccharide consisting mainly of D-galactose units. On about every tenth D-galactopyranose unit one of the hydroxyl groups is esterified with sulphuric acid which is neutralised by calcium, magnesium, potassium or sodium. It is extracted from certain natural strains of marine algae of the families Gelidiaceae und Sphaerococcaceae and related red algae of the class Rhodophyceae

Einecs 232-658-1

Assay The threshold gel concentration should not be higher than 0,25 %

Description Agar is odourless or has a slight characteristic odour. Unground agar usually occurs in bundles consisting of thin, membranous, agglutinated strips, or in cut, flaked or granulated forms. It may be light yellowish-orange, yellowish-grey to pale yellow, or colourless. It is tough when damp, brittle when dry. Powdered agar is white to yellowish-white or pale yellow. When examined in water under a microscope, the agar appears granular and somewhat filamentous. A few fragments of the spicules of sponges and a few frustules of diatoms may be present. In chloral hydrate solution, the powdered agar appears more transparent than in water, more or less granular, striated, angular and occasionally contains frustules of diatoms. Gel strength may be standardised by the addition of dextrose and maltodextrines or sucrose

Identification

A. Solubility Insoluble in cold water; soluble in boiling water

Purity

Loss on drying Not more than 22 % (105 °C, 5 hours)

Ash Not more than 6,5 % on the anhydrous basis determined at 550 °C

Acid-insoluble ash (insoluble in approximately 3N Hydrochloric acid) Not more than 0,5 % determined at 550 °C on the anhydrous basis

Insoluble matter (in hot water) Not more than 1,0 %

Starch Not detectable by the following method: to a 1 in 10 solution of the sample add a few drops of iodine solution. No blue colour is produced

Gelatin and other proteins Dissolve about 1 g of agar in 100 ml of boiling water and allow to cool of about 50 °C. To 5 ml of the solution add 5 ml of trinitrophenol solution (1 g of anhydrous trinitrophenol/100 ml of hot water). No turbidity appears within 10 minutes

Water absorption Place 5 g to agar in a 100 ml graduated cylinder, fill to the mark with water, mix and allow to stand at about 25 °C for 24 hours. Pour the contents of the cylinder through moistened glass wool, allowing the water to drain into a second 100 ml graduated cylinder. Not more than 75 ml of water is obtained

Arsenic Not more than 3 mg/kg

Lead Not more than 5 mg/kg

Mercury Not more than 1 mg/kg

Ca