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Document 32008L0084

Commission Directive 2008/84/EC of 27 August 2008 laying down specific purity criteria on food additives other than colours and sweeteners (Text with EEA relevance)(Codified version)

OJ L 253, 20.9.2008, p. 1–175 (BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

No longer in force, Date of end of validity: 30/11/2012; Repealed by 32012R0231

ELI: http://data.europa.eu/eli/dir/2008/84/oj

20.9.2008   

EN

Official Journal of the European Union

L 253/1


COMMISSION DIRECTIVE 2008/84/EC

of 27 August 2008

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

(Text with EEA relevance)

(Codified version)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption (1), and in particular Article 3(3)(a) thereof,

Whereas:

(1)

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

(2)

It is necessary to establish purity criteria for all additives other than colours and sweeteners mentioned in European Parliament and Council Directive 95/2/EC of 20 February 1995 on food additives other than colours and sweeteners (4).

(3)

It is necessary to take into account the specifications and analytical techniques for additives as set out in the Codex Alimentarius as drafted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA).

(4)

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

(5)

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

(6)

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

HAS ADOPTED THIS DIRECTIVE:

Article 1

The purity criteria referred to in Article 3(3)(a) of Directive 89/107/EEC for food additives other than colours and sweeteners, as mentioned in Directive 95/2/EC, are set out in Annex I to this Directive.

Article 2

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

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

Article 3

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

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 27 August 2008.

For the Commission

The President

José Manuel BARROSO


(1)  OJ L 40, 11.2.1989, p. 27.

(2)  OJ L 339, 30.12.1996, p. 1.

(3)  See Annex II, part A.

(4)  OJ L 61, 18.3.1995, p. 1.


ANNEX I

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

E 170 (i) CALCIUM CARBONATE

Purity criteria for this additive are the same as set out for this additive in the Annex to Commission Directive 95/45/EC (1).

E 200 SORBIC ACID

Definition

 

Chemical name

Sorbic acid

Trans, trans-2,4-hexadienoic acid

Einecs

203-768-7

Chemical formula

C6H8O2

Molecular weight

112,12

Assay

Content not less than 99 % on the anhydrous basis

Description

Colourless needles or white free flowing powder, having a slight characteristic odour and showing no change in colour after heating for 90 minutes at 105 oC

Identification

 

A.

Melting range

Between 133 oC and 135 oC, after vacuum drying for four hours in a sulphuric acid desiccator

B.

Spectrometry

An isopropanol solution (1 in 4 000 000) shows absorbance maximum at 254 ± 2 nm

C.

Positive test for double bonds

 

D.

Sublimation point

80 oC

Purity

 

Water content

Not more than 0,5 % (Karl Fischer method)

Sulphated ash

Not more than 0,2 %

Aldehydes

Not more than 0,1 % (as formaldehyde)

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 202 POTASSIUM SORBATE

Definition

 

Chemical name

Potassium sorbate

Potassium (E, E)-2,4-hexadienoate

Potassium salt of trans, trans 2,4-hexadienoic acid

Einecs

246-376-1

Chemical formula

C6H7O2K

Molecular weight

150,22

Assay

Content not less than 99 % on the dried basis

Description

White crystalline powder showing no change in colour after heating for 90 minutes at 105 oC

Identification

 

A.

Melting range of sorbic acid isolated by acidification and not recrystallised 133 oC to 135 oC after vacuum drying in a sulphuric acid desiccator

 

B.

Positive tests for potassium and for double bonds

 

Purity

 

Loss on drying

Not more than 1,0 % (105 oC, 3h)

Acidity or alkalinity

Not more than about 1,0 % (as sorbic acid or K2CO3)

Aldehydes

Not more than 0,1 %, calculated as formaldehyde

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 203 CALCIUM SORBATE

Definition

 

Chemical name

Calcium sorbate

Calcium salts of trans, trans-2,4-hexadienoic acid

Einecs

231-321-6

Chemical formula

C12H14O4Ca

Molecular weight

262,32

Assay

Content not less than 98 % on the dried basis

Description

Fine white crystalline powder not showing any change in colour after heating at 105 oC for 90 minutes

Identification

 

A.

Melting range of sorbic acid isolated by acidification and not recrystallised 133 oC to 135 oC after vacuum drying in a sulphuric acid desiccator

 

B.

Positive tests for calcium and for double bonds

 

Purity

 

Loss on drying

Not more than 2,0 %, determined by vacuum drying for four hours in a sulphuric acid desiccator

Aldehydes

Not more than 0,1 % (as formaldehyde)

Fluoride

Not more than 10 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 210 BENZOIC ACID

Definition

 

Chemical name

Benzoic acid

Benzenecarboxylic acid

Phenylcarboxylic acid

Einecs

200-618-2

Chemical formula

C7H6O2

Molecular weight

122,12

Assay

Content not less than 99,5 % on the anhydrous basis

Description

White crystalline powder

Identification

 

A.

Melting range

121,5 oC to 123,5 oC

B.

Positive sublimation test and test for benzoate

 

Purity

 

Loss on drying

Not more than 0,5 % after drying for three hours over sulphuric acid

pH

About 4 (solution in water)

Sulphated ash

Not more than 0,05 %

Chlorinated organic compounds

Not more than 0,07 % expressed as chloride corresponding to 0,3 % expressed as monochlorobenzoic acid

Readily oxidisable substances

Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4 in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required

Readily carbonisable substances

A cold solution of 0,5 g of benzoic acid in 5 ml of 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC (3), 0,3 ml of ferric chloride TSC (4), 0,1 ml of copper sulphate TSC (5) and 4,4 ml of water

Polycyclic acids

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 211 SODIUM BENZOATE

Definition

 

Chemical name

Sodium benzoate

Sodium salt of benzenecarboxylic acid

Sodium salt of phenylcarboxylic acid

Einecs

208-534-8

Chemical formula

C7H5O2Na

Molecular weight

144,11

Assay

Not less than 99 % of C7H5O2Na, after drying at 105 oC for four hours

Description

A white, almost odourless, crystalline powder or granules

Identification

 

A.

Solubility

Freely soluble in water, sparingly soluble in ethanol

B.

Melting range for benzoic acid

Melting range of benzoic acid isolated by acidification and not recrystallised 121,5 oC to 123,5 oC, after drying in a sulphuric acid desiccator

C.

Positive tests for benzoate and for sodium

 

Purity

 

Loss on drying

Not more than 1,5 % after drying at 105 oC for four hours

Readily oxidisable substances

Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4 in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required

Polycyclic acids

On fractional acidification of a (neutralised) solution of sodium benzoate, the first precipitate must not have a different melting range from that of benzoic acid

Chlorinated organic compounds

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

Degree of acidity or alkalinity

Neutralisation of 1 g of sodium benzoate, in the presence of phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 212 POTASSIUM BENZOATE

Definition

 

Chemical name

Potassium benzoate

Potassium salt of benzenecarboxylic acid

Potassium salt of phenylcarboxylic acid

Einecs

209-481-3

Chemical formula

C7H5KO2·3H2O

Molecular weight

214,27

Assay

Content not less than 99 % C7H5KO2 after drying at 105 oC to constant weight

Description

White crystalline powder

Identification

 

A.

Melting range of benzoic acid isolated by acidification and not recrystallised 121,5 oC to 123,5 oC, after vacuum drying in a sulphuric acid desiccator

 

B.

Positive tests for benzoate and for potassium

 

Purity

 

Loss on drying

Not more than 26,5 %, determined by drying at 105 oC

Chlorinated organic compounds

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

Readily oxidisable substances

Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4 in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required

Readily carbonisable substances

A cold solution of 0,5 g of benzoic acid in 5 ml 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of ferric chloride TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of water

Polycyclic acids

On fractional acidification of a (neutralised) solution of potassium benzoate, the first precipitate must not have a different melting range from that of benzoic acid

Degree of acidity or alkalinity

Neutralisation of 1 g of potassium benzoate, in the presence of phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 213 CALCIUM BENZOATE

Synonyms

Monocalcium benzoate

Definition

 

Chemical name

Calcium benzoate

Calcium dibenzoate

Einecs

218-235-4

Chemical formula

Anhydrous:

C14H10O4Ca

Monohydrate:

C14H10O4Ca· H2O

Trihydrate:

C14H10O4Ca· 3H2O

Molecular weight

Anhydrous:

282,31

Monohydrate:

300,32

Trihydrate:

336,36

Assay

Content not less than 99 % after drying at 105 oC

Description

White or colourless crystals, or white powder

Identification

 

A.

Melting range of benzoic acid isolated by acidification and not recrystallised 121,5 oC to 123,5 oC, after vacuum drying in a sulphuric acid desiccator

 

B.

Positive tests for benzoate and for calcium

 

Purity

 

Loss on drying

Not more than 17,5 % determined by drying at 105 oC to constant weight

Water insoluble matter

Not more than 0,3 %

Chlorinated organic compounds

Not more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monochlorobenzoic acids

Readily oxidisable substances

Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4 in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required

Readily carbonisable substances

Cold solution of 0,5 g of benzoic acid in 5 ml of 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of ferric chloride TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of water

Polycyclic acids

On fractional acidification of a (neutralised) solution of calcium benzoate, the first precipitate must not be a different melting range from that of benzoic acid

Degree of acidity or alkalinity

Neutralisation of 1 g of calcium benzoate, in the presence of phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl

Fluoride

Not more than 10 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 214 ETHYL p-HYDROXYBENZOATE

Synonyms

Ethylparaben

Ethyl p-oxybenzoate

Definition

 

Chemical name

Ethyl-p-hydroxybenzoate

Ethyl ester of p-hydroxybenzoic acid

Einecs

204-399-4

Chemical formula

C9H10O3

Molecular weight

166,8

Assay

Content not less than 99,5 % after drying for two hours at 80 oC

Description

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

Identification

 

A.

Melting range

115 oC to 118 oC

B.

Positive test for p-hydroxybenzoate

Melting range of p-hydroxybenzoic acid isolated by acidification and not recrystallised: 213 oC to 217 oC, after vacuum drying in a sulphuric acid desiccator

C.

Positive test for alcohol

 

Purity

 

Loss on drying

Not more than 0,5 % after drying for two hours at 80 oC

Sulphated ash

Not more than 0,05 %

p-Hydroxybenzoic acid and salicylic acid

Not more than 0,35 % expressed as p-hydroxybenzoic acid

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 215 SODIUM ETHYL p-HYDROXYBENZOATE

Definition

 

Chemical name

Sodium ethyl p-hydroxybenzoate

Sodium compound of the ethyl ester of p-hydroxybenzoic acid

Einecs

252-487-6

Chemical formula

C9H9O3Na

Molecular weight

188,8

Assay

Content of ethylester of p-hydroxybenzoic acid not less than 83 % on the anhydrous basis

Description

White, crystalline hygroscopic powder

Identification

 

A.

Melting range

115 oC to 118 oC, after vacuum drying in a sulphuric acid desiccator

B.

Positive test for p-hydroxybenzoate

Melting range of p-hydroxybenzoic acid derived from the sample is 213 oC to 217 oC

C.

Positive test for sodium

 

D.

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

 

Purity

 

Loss on drying

Not more than 5 %, determined by vacuum drying in a sulphuric acid desiccator

Sulphated ash

37 to 39 %

p-Hydroxybenzoic acid and salicylic acid

Not more than 0,35 % expressed as p-hydroxybenzoic acid

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 218 METHYL p-HYDROXYBENZOATE

Synonyms

Methylparaben

Methyl-p-oxybenzoate

Definition

 

Chemical name

Methyl p-hydroxybenzoate

Methyl ester of p-hydroxybenzoic acid

Einecs

243-171-5

Chemical formula

C8H8O3

Molecular weight

152,15

Assay

Content not less than 99 % after drying for two hours at 80 oC

Description

Almost odourless, small colourless crystals or white crystalline powder

Identification

 

A.

Melting range

125 oC to 128 oC

B.

Positive test for p-hydroxybenzoate

Melting range of p-hydroxybenzoic acid derived from the sample is 213 oC to 217 oC after drying for two hours at 80 oC

Purity

 

Loss on drying

Not more than 0,5 %, after drying for two hours at 80 oC

Sulphated ash

Not more than 0,05 %

p-Hydroxybenzoic acid and salicylic acid

Not more than 0,35 % expressed as p-hydroxybenzoic acid

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 219 SODIUM METHYL p-HYDROXYBENZOATE

Definition

 

Chemical name

Sodium methyl p-hydroxybenzoate

Sodium compound of the methylester of p-hydroxybenzoic acid

Chemical formula

C8H7O3Na

Molecular weight

174,15

Assay

Content not less than 99,5 % on the anhydrous basis

Description

White, hygroscopic powder

Identification

 

A.

The white precipitate formed by acidifying with hydrochloric acid a 10 % (w/v) aqueous solution of the sodium derivative of methyl p-hydroxybenzoate (using litmus paper as indicator) shall, when washed with water and dried at 80 oC for two hours, have a melting range of 125 oC to 128 oC

 

B.

Positive test for sodium

 

C.

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

 

Purity

 

Water content

Not more than 5 % (Karl Fischer method)

Sulphated ash

40 % to 44,5 % on the anhydrous basis

p-Hydroxybenzoic acid and salicylic acid

Not more than 0,35 % expressed as p-hydroxybenzoic acid

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 220 SULPHUR DIOXIDE

Definition

 

Chemical name

Sulphur dioxide

Sulphurous acid anhydride

Einecs

231-195-2

Chemical formula

SO2

Molecular weight

64,07

Assay

Content not less than 99 %

Description

Colourless, non-flammable gas with strong pungent suffocating odour

Identification

 

A.

Positive test for sulphurous substances

 

Purity

 

Water content

Not more than 0,05 %

Non-volatile residue

Not more than 0,01 %

Sulphur trioxide

Not more than 0,1 %

Selenium

Not more than 10 mg/kg

Other gases not normally present in the air

No trace

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 221 SODIUM SULPHITE

Definition

 

Chemical name

Sodium sulphite (anhydrous or heptahydrate)

Einecs

231-821-4

Chemical formula

Anhydrous:

Na2SO3

Heptahydrate:

Na2SO37H2O

Molecular weight

Anhydrous:

126,04

Heptahydrate:

252,16

Assay

Anhydrous:

Not less than 95 % of Na2SO3 and not less than 48 % of SO2

Heptahydrate:

Not less than 48 % of Na2SO3 and not less than 24 % of SO2

Description

White crystalline powder or colourless crystals

Identification

 

A.

Positive tests for sulphite and for sodium

 

B.

pH of a 10 % solution (anhydrous) or a 20 % solution (heptahydrate) between 8,5 and 11,5

 

Purity

 

Thiosulphate

Not more than 0,1 % based on the SO2 content

Iron

Not more than 50 mg/kg based on the SO2 content

Selenium

Not more than 10 mg/kg based on the SO2 content

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 222 SODIUM BISULPHITE

Definition

 

Chemical name

Sodium bisulphite

Sodium hydrogen sulphite

Einecs

231-921-4

Chemical formula

NaHSO3 in aqueous solution

Molecular weight

104,06

Assay

Content not less than 32 % w/w NaHSO3

Description

A clear, colourless to yellow solution

Identification

 

A.

Positive tests for sulphite and for sodium

 

B.

pH of a 10 % aqueous solution between 2,5 and 5,5

 

Purity

 

Iron

Not more than 50 mg/kg of Na2SO3 based on the SO2 content

Selenium

Not more than 10 mg/kg based on the SO2 content

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 223 SODIUM METABISULPHITE

Synonyms

Pyrosulphite

Sodium pyrosulphite

Definition

 

Chemical name

Sodium disulphite

Disodium pentaoxodisulphate

Einecs

231-673-0

Chemical formula

Na2S2O5

Molecular weight

190,11

Assay

Content not less than 95 % Na2S2O5 and not less than 64 % of SO2

Description

White crystals or crystalline powder

Identification

 

A.

Positive tests for sulphite and for sodium

 

B.

pH of a 10 % aqueous solution between 4,0 and 5,5

 

Purity

 

Thiosulphate

Not more than 0,1 % based on the SO2 content

Iron

Not more than 50 mg/kg based on the SO2 content

Selenium

Not more than 10 mg/kg based on the SO2 content

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 224 POTASSIUM METABISULPHITE

Synonyms

Potassium pyrosulphite

Definition

 

Chemical name

Potassium disulphite

Potassium pentaoxo disulphate

Einecs

240-795-3

Chemical formula

K2S2O5

Molecular weight

222,33

Assay

Content not less than 90 % of K2S2O5 and not less than 51,8 % of SO2, the remainder being composed almost entirely of potassium sulphate

Description

Colourless crystals or white crystalline powder

Identification

 

A.

Positive tests for sulphite and for potassium

 

Purity

 

Thiosulphate

Not more than 0,1 % based on the SO2 content

Iron

Not more than 50 mg/kg based on the SO2 content

Selenium

Not more than 10 mg/kg based on the SO2 content

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 226 CALCIUM SULPHITE

Definition

 

Chemical name

Calcium sulphite

Einecs

218-235-4

Chemical formula

CaSO3·2H2O

Molecular weight

156,17

Assay

Content not less than 95 % of CaSO3·2H2O and not less than 39 % of SO2

Description

White crystals or white crystalline powder

Identification

 

A.

Positive tests for sulphite and for calcium

 

Purity

 

Iron

Not more than 50 mg/kg based on the SO2 content

Selenium

Not more than 10 mg/kg based on the SO2 content

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 227 CALCIUM BISULPHITE

Definition

 

Chemical name

Calcium bisulphite

Calcium hydrogen sulphite

Einecs

237-423-7

Chemical formula

Ca(HSO3)2

Molecular weight

202,22

Assay

6 to 8 % (w/v) of sulphur dioxide and 2,5 to 3,5 % (w/v) of calcium dioxide corresponding to 10 to 14 % (w/v) of calcium bisulphite [Ca(HSO3)2]

Description

Clear greenish-yellow aqueous solution having a distinct odour of sulphur dioxide

Identification

 

A.

Positive tests for sulphite and for calcium

 

Purity

 

Iron

Not more than 50 mg/kg based on the SO2 content

Selenium

Not more than 10 mg/kg based on the SO2 content

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 228 POTASSIUM BISULPHITE

Definition

 

Chemical name

Potassium bisulphite

Potassium hydrogen sulphite

Einecs

231-870-1

Chemical formula

KHSO3 in aqueous solution

Molecular weight

120,17

Assay

Content not less than 280 g KHSO3 per litre (or 150 g SO2 per litre)

Description

Clear colourless aqueous solution

Identification

 

A.

Positive tests for sulphite and for potassium

 

Purity

 

Iron

Not more than 50 mg/kg based on the SO2 content

Selenium

Not more than 10 mg/kg based on the SO2 content

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 230 BIPHENYL

Synonyms

Diphenyl

Definition

 

Chemical name

1,1′-biphenyl

Phenylbenzene

Einecs

202-163-5

Chemical formula

C12H10

Molecular weight

154,20

Assay

Content not less than 99,8 %

Description

White or pale yellow to amber crystalline solid having a characteristic odour

Identification

 

A.

Melting range

68,5 oC to 70,5 oC

B.

Distillation range

It distils completely within a 2,5 oC range between 252,5 oC and 257,5 oC

Purity

 

Benzene

Not more than 10 mg/kg

Aromatic amines

Not more than 2 mg/kg (as aniline)

Phenol derivatives

Not more than 5 mg/kg (as phenol)

Readily carbonisable substances

Cold solution of 0,5 g of biphenyl in 5 ml of 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of ferric chloride TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of water

Terphenyl and higher polyphenyl derivatives

Not more than 0,2 %

Polycyclic aromatic hydrocarbons

Absent

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 231 ORTHOPHENYLPHENOL

Synonyms

Orthoxenol

Definition

 

Chemical name

(1,1'-Biphenyl)-2-ol

2-Hydroxydiphenyl

o-Hydroxydiphenyl

Einecs

201-993-5

Chemical formula

C12H10O

Molecular weight

170,20

Assay

Content not less than 99 %

Description

White or slightly yellowish crystalline powder

Identification

 

A.

Melting range

56 oC to 58 oC

B.

Positive test for phenolate

An ethanolic solution (1 g in 10 ml) produces a green colour on addition of 10 % ferric chloride solution

Purity

 

Sulphated ash

Not more than 0,05 %

Diphenyl ether

Not more than 0,3 %

p-Phenylphenol

Not more than 0,1 %

1-Naphthol

Not more than 0,01 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 232 SODIUM ORTHOPHENYLPHENOL

Synonyms

Sodium orthophenylphenate

Sodium salt ofo-phenylphenol

Definition

 

Chemical name

Sodium orthophenylphenol

Einecs

205-055-6

Chemical formula

C12H9ONa· 4H2O

Molecular weight

264,26

Assay

Content not less than 97 % of C12H9ONa· 4H2O

Description

White or slightly yellowish crystalline powder

Identification

 

A.

Positive tests for phenolate and for sodium

 

B.

Melting range of orthophenylphenol isolated by acidification and not recrystallised derived from the sample 56 oC to 58 oC after drying in a sulphuric acid desiccator

 

C.

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

 

Purity

 

Diphenylether

Not more than 0,3 %

p-phenylphenol

Not more than 0,1 %

1-naphthol

Not more than 0,01 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 233 THIABENDAZOLE

Definition

 

Chemical name

4-(2-benzimidazolyl)thiazole

2-(4-thiazolyl)-1H-benzimidazole

Einecs

205-725-8

Chemical formula

C10H7N3S

Molecular weight

201,26

Assay

Content not less than 98 % on the anhydrous basis

Description

White, or almost white, odourless powder

Identification

 

A.

Melting range

296 oC to 303 oC

B.

Spectrometry

Absorption maxima in 0,1 N HCl (0,0005 % w/v) at 302 nm, 258 nm and 243 nm

Formula

at 302 nm ± 2 nm: approximately 1 230

Formula

at 258 nm ± 2 nm: approximately 200

Formula

at 243 nm ± 2 nm: approximately 620

Ratio of absorption 243 nm/302 nm = 0,47 to 0,53

Ratio of absorption 258 nm/302 nm = 0,14 to 0,18

Purity

 

Water content

Not more than 0,5 % (Karl Fischer method)

Sulphated ash

Not more than 0,2 %

Selenium

Not more than 3 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 234 NISIN

Definition

Nisin consists of several closely related polypeptides produced by natural strains of Streptococcus lactis, Lancefield group N

Einecs

215-807-5

Chemical formula

C143H230N42O37S7

Molecular weight

3 354 ,12

Assay

Nisin concentrate contains not less than 900 units per mg in a mixture of non-fat milk solids and a minimum sodium chloride content of 50 %

Description

White powder

Purity

 

Loss on drying

Not more than 3 % when dried to constant weight at 102 oC to 103 oC

Arsenic

Not more than 1 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 235 NATAMYCIN

Synonyms

Pimaricin

Definition

Natamycin is a fungicide of the polyene macrolide group, and is produced by natural strains of Streptomyces natalensis or of Streptococcus lactis

Einecs

231-683-5

Chemical formula

C33H47O13N

Molecular weight

665,74

Assay

Content not less than 95 % on the anhydrous basis

Description

White to creamy-white crystalline powder

Identification

 

A.

Colour reactions

On adding a few crystals of natamycin on a spot plate, to a drop of:

concentrated hydrochloric acid, a blue colour develops,

concentrated phosphoric acid, a green colour develops,

which changes into pale red after a few minutes

B.

Spectrometry

A 0,0005 % w/v solution in 1 % methanolic acetic acid solution has absorption maxima at about 290 nm, 303 nm and 318 nm, a shoulder at about 280 nm and exhibits minima at about 250 nm, 295,5 nm and 311 nm

C.

pH

5,5 to 7,5 (1 % w/v solution in previously neutralised mixture of 20 parts dimethylformamide and 80 parts of water)

D.

Specific rotation

[α]D 20 = + 250o to + 295o (a 1 % w/v solution in glacial acetic acid, at 20 oC and calculated with reference to the dried material)

Purity

 

Loss on drying

Not more than 8 % (over P2O5, in vacuum at 60 oC to constant weight)

Sulphated ash

Not more than 0,5 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

Microbiological criteria: total viable count

Not more than 100/g

E 239 HEXAMETHYLENE TETRAMINE

Synonyms

Hexamine

Methenamine

Definition

 

Chemical name

1,3,5,7-Tetraazatricyclo [3.3.1.13,7]-decane, hexamethylenetetramine

Einecs

202-905-8

Chemical formula

C6H12N4

Molecular weight

140,19

Assay

Content not less than 99 % on the anhydrous basis

Description

Colourless or white crystalline powder

Identification

 

A.

Positive tests for formaldehyde and for ammonia

 

B.

Sublimation point approximately 260 oC

 

Purity

 

Loss on drying

Not more than 0,5 % after drying at 105 oC in vacuum over P2O5 for two hours

Sulphated ash

Not more than 0,05 %

Sulphates

Not more than 0,005 % expressed as SO4

Chlorides

Not more than 0,005 % expressed as Cl

Ammonium salts

Not detectable

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 242 DIMETHYL DICARBONATE

Synonyms

DMDC

Dimethyl pyrocarbonate

Definition

 

Chemical name

Dimethyl dicarbonate

Pyrocarbonic acid dimethyl ester

Einecs

224-859-8

Chemical formula

C4H6O5

Molecular weight

134,09

Assay

Content not less than 99,8 %

Description

Colourless liquid, decomposes in aqueous solution. It is corrosive to skin and eyes and toxic by inhalation and ingestion

Identification

 

A.

Decomposition

After dilution positive tests for CO2 and methanol

B.

Melting point

17 oC

Boiling point

172 oC with decomposition

C.

Density 20 oC

Approximately 1,25 g/cm3

D.

Infrared spectrum

Maxima at 1 156 and 1 832 cm- 1

Purity

 

Dimethyl carbonate

Not more than 0,2 %

Chlorine, total

Not more than 3 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 249 POTASSIUM NITRITE

Definition

 

Chemical name

Potassium nitrite

Einecs

231-832-4

Chemical formula

KNO2

Molecular weight

85,11

Assay

Content not less than 95 % on the anhydrous basis (6)

Description

White or slightly yellow, deliquescent granules

Identification

 

A.

Positive tests for nitrite and for potassium

 

B.

pH of a 5 % solution:

Not less than 6,0 and not more than 9,0

Purity

 

Loss on drying

Not more than 3 % after drying for four hours over silica gel

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 250 SODIUM NITRITE

Definition

 

Chemical name

Sodium nitrite

Einecs

231-555-9

Chemical formula

NaNO2

Molecular weight

69,00

Assay

Content not less than 97 % on the anhydrous basis (7)

Description

White crystalline powder or yellowish lumps

Identification

 

A.

Positive tests for nitrite and for sodium

 

Purity

 

Loss on drying

Not more than 0,25 % after drying over silica gel for four hours

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 251 SODIUM NITRATE

1.   SOLID SODIUM NITRATE

Synonyms

Chile saltpetre

Cubic or soda nitre

Definition

 

Chemical name

Sodium nitrate

Einecs

231-554-3

Chemical formula

NaNO3

Molecular weight

85,00

Assay

Content not less than 99 % after drying

Description

White crystalline, slightly hygroscopic powder

Identification

 

A.

Positive tests for nitrate and for sodium

 

B.

pH of a 5 % solution

Not less than 5,5 and more than 8,3

Purity

 

Loss on drying

Not more than 2 % after drying at 105 oC for four hours

Nitrites

Not more than 30 mg/kg expressed as NaNO2

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 251 SODIUM NITRATE

2.   LIQUID SODIUM NITRATE

Definition

Liquid sodium nitrate is an aqueous solution of sodium nitrate as the direct result of the chemical reaction between sodium hydroxide and nitric acid in stoechiometric amounts, without subsequent crystallisation. Standardised forms prepared from liquid sodium nitrate meeting these specifications may contain nitric acid in excessive amounts, if clearly stated or labelled.

Chemical name

Sodium nitrate

Einecs

231-554-3

Chemical formula

NaNO3

Molecular weight

85,00

Assay

Content between 33,5 % and 40,0 % of NaNO3

Description

Clear colourless liquid

Identification

 

A.

Positive tests for nitrate and for sodium

 

B.

pH

Not less than 1,5 and not more than 3,5

Purity

 

Free nitric acid

Not more than 0,01 %

Nitrites

Not more than 10 mg/kg expressed as NaNO2

Arsenic

Not more than 1 mg/kg

Lead

Not more than 1 mg/kg

Mercury

Not more than 0,3 mg/kg

This specification refers to a 35 % aqueous solution

 

E 252 POTASSIUM NITRATE

Synonyms

Chile saltpetre

Cubic or soda nitre

Definition

 

Chemical name

Potassium nitrate

Einecs

231-818-8

Chemical formula

KNO3

Molecular weight

101,11

Assay

Content not less than 99 % on the anhydrous basis

Description

White crystalline powder or transparent prisms having a cooling, saline, pungent taste

Identification

 

A.

Positive tests for nitrate and for potassium

 

B.

pH of a 5 % solution

Not less than 4,5 and not more than 8,5

Purity

 

Loss on drying

Not more than 1 % after drying at 105 oC for four hours

Nitrites

Not more than 20 mg/kg expressed as KNO2

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 260 ACETIC ACID

Definition

 

Chemical name

Acetic acid

Ethanoic acid

Einecs

200-580-7

Chemical formula

C2H4O2

Molecular weight

60,05

Assay

Content not less than 99,8 %

Description

Clear, colourless liquid having a pungent, characteristic odour

Identification

 

A.

Boiling point

118 oC at 760 mm pressure (of mercury)

B.

Specific gravity

About 1,049

C.

A one in three solution gives positive tests for acetate

 

D.

Solidification point

Not lower than 14,5 oC

Purity

 

Non-volatile residue

Not more than 100 mg/kg

Formic acid, formates and other oxidisable substances

Not more than 1 000 mg/kg expressed as formic acid

Readily oxidisable substances

Dilute 2 ml of the sample in a glass-stoppered container with 10 ml of water and add 0,1 ml of 0,1 N potassium permanganate. The pink colour does not change to brown within 30 minutes

Arsenic

Not more than 1 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 261 POTASSIUM ACETATE

Definition

 

Chemical name

Potassium acetate

Einecs

204-822-2

Chemical formula

C2H3O2K

Molecular weight

98,14

Assay

Content not less than 99 % on the anhydrous basis

Description

Colourless, deliquescent crystals or a white crystalline powder, odourless or with a faint acetic odour

Identification

 

A.

pH of a 5 % aqueous solution

Not less than 7,5 and not more than 9,0

B.

Positive tests for acetate and for potassium

 

Purity

 

Loss on drying

Not more than 8 % after drying at 150 oC for two hours

Formic acid, formates and other oxidisable substances

Not more than 1 000 mg/kg expressed as formic acid

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 262 (i) SODIUM ACETATE

Definition

 

Chemical name

Sodium acetate

Einecs

204-823-8

Chemical formula

C2H3NaO2·nH2O (n = 0 or 3)

Molecular weight

Anhydrous:

82,03

Trihydrate:

136,08

Assay

Content (for both of anhydrous and trihydrate form) not less than 98,5 % on the anhydrous basis

Description

Anhydrous:

White, odourless, granular, hygroscopic powder

Trihydrate:

Colourless, transparent crystals or a granular crystalline powder, odourless or with a faint, acetic odour. Effloresces in warm, dry air

Identification

 

A.

pH of a 1 % aqueous solution

Not less than 8,0 and not more than 9,5

B.

Positive tests for acetate and for sodium

 

Purity

 

Loss on drying

Anhydrous:

Not more than 2 % (120 oC, 4 hours)

Trihydrate:

Between 36 and 42 % (120 oC, 4 hours)

Formic acid, formates and other oxidisable substances

Not more than 1 000 mg/kg expressed as formic acid

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 262 (ii) SODIUM DIACETATE

Definition

Sodium diacetate is a molecular compound of sodium acetate and acetic acid

Chemical name

Sodium hydrogen diacetate

Einecs

204-814-9

Chemical formula

C4H7NaO4·nH2O (n = 0 or 3)

Molecular weight

142,09 (anhydrous)

Assay

Content 39 to 41 % of free acetic acid and 58 to 60 % of sodium acetate

Description

White, hygroscopic crystalline solid with an acetic odour

Identification

 

A.

pH of a 10 % aqueous solution

Not less than 4,5 and not more than 5,0

B.

Positive tests for acetate and for sodium

 

Purity

 

Water content

Not more than 2 % (Karl Fischer method)

Formic acid, formates and other oxidisable substances

Not more than 1 000 mg/kg expressed as formic acid

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 263 CALCIUM ACETATE

Definition

 

Chemical name

Calcium acetate

Einecs

200-540-9

Chemical formula

Anhydrous:

C4H6O4Ca

Monohydrate:

C4H6O4Ca· H2O

Molecular weight

Anhydrous:

158,17

Monohydrate:

176,18

Assay

Content not less than 98 % on the anhydrous basis

Description

Anhydrous calcium acetate is a white, hygroscopic, bulky, crystalline solid with a slightly bitter taste. A slight odour of acetic acid may be present. The monohydrate may be needles, granules or powder

Identification

 

A.

pH of a 10 % aqueous solution

Not less than 6,0 and not more than 9,0

B.

Positive tests for acetate and for calcium

 

Purity

 

Loss on drying

Not more than 11 % after drying (155 oC to constant weight, for the monohydrate)

Water insoluble matter

Not more than 0,3 %

Formic acid, formates and other oxidisable substances

Not more than 1 000 mg/kg expressed as formic acid

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 270 LACTIC ACID

Definition

 

Chemical name

Lactic acid

2-Hydroxypropionic acid

1-Hydroxyethane-1-carboxylic acid

Einecs

200-018-0

Chemical formula

C3H6O3

Molecular weight

90,08

Assay

Content not less than 76 % and not more than 84 %

Description

Colourless or yellowish, nearly odourless, syrupy liquid with an acid taste, consisting of a mixture of lactic acid (C3H6O3) and lactic acid lactate (C6H10O5). It is obtained by the lactic fermentation of sugars or is prepared synthetically

Note:

Lactic acid is hygroscopic and when concentrated by boiling, it condenses to form lactic acid lactate, which on dilution and heating hydrolyzes to lactic acid

 

Identification

 

A.

Positive test for lactate

 

Purity

 

Sulphated ash

Not more than 0,1 %

Chloride

Not more than 0,2 %

Sulphate

Not more than 0,25 %

Iron

Not more than 10 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

Note:

This specification refers to a 80 % aqueous solution; for weaker aqueous solutions, calculate values corresponding to their lactic acid content

 

E 280 PROPIONIC ACID

Definition

 

Chemical name

Propionic acid

Propanoic acid

Einecs

201-176-3

Chemical formula

C3H6O2

Molecular weight

74,08

Assay

Content not less than 99,5 %

Description

Colourless or slightly yellowish, oily liquid with a slightly pungent odour

Indentification

 

A.

Melting point

- 22 oC

B.

Distillation range

138,5 oC to 142,5 oC

Purity

 

Non-volatile residue

Not more than 0,01 % when dried at 140 oC to constant weight

Aldehydes

Not more than 0,1 % expressed as formaldehyde

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 281 SODIUM PROPIONATE

Definition

 

Chemical name

Sodium propionate

Sodium propanoate

Einecs

205-290-4

Chemical formula

C3H5O2Na

Molecular weight

96,06

Assay

Content not less than 99 % after drying for two hours at 105 oC

Description

White crystalline hygroscopic powder, or a fine white powder

Identification

 

A.

Positive tests for propionate and for sodium

 

B.

pH of a 10 % aqueous solution

Not less than 7,5 and not more than 10,5

Purity

 

Loss on drying

Not more than 4 % determined by drying for two hours at 105 oC

Water insolubles

Not more than 0,1 %

Iron

Not more than 50 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 282 CALCIUM PROPIONATE

Definition

 

Chemical name

Calcium propionate

Einecs

223-795-8

Chemical formula

C6H10O4Ca

Molecular weight

186,22

Assay

Content not less than 99 %, after drying for two hours at 105 oC

Description

White crystalline powder

Identification

 

A.

Positive tests for propionate and for calcium

 

B.

pH of a 10 % aqueous solution

Between 6,0 and 9,0

Purity

 

Loss on drying

Not more than 4 %, determined by drying for two hours at 105 oC

Water insolubles

Not more than 0,3 %

Iron

Not more than 50 mg/kg

Fluoride

Not more than 10 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 283 POTASSIUM PROPIONATE

Definition

 

Chemical name

Potassium propionate

Potassium propanoate

Einecs

206-323-5

Chemical formula

C3H5KO2

Molecular weight

112,17

Assay

Content not less than 99 % after drying for two hours at 105 oC

Description

White crystalline powder

Identification

 

A.

Positive tests for propionate and for potassium

 

Purity

 

Loss on drying

Not more than 4 %, determined by drying for two hours at 105 oC

Water-insoluble substances

Not more than 0,3 %

Iron

Not more than 30 mg/kg

Fluoride

Not more than 10 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 284 BORIC ACID

Synonyms

Boracic acid

Orthoboric acid

Borofax

Definition

 

Einecs

233-139-2

Chemical formula

H3BO3

Molecular weight

61,84

Assay

Content not less than 99,5 %

Description

Colourless, odourless, transparent crystals or white granules or powder; slightly unctuous to the touch; occurs in nature as the mineral sassolite

Identification

 

A.

Melting point

At approximately 171 oC

B.

Burns with a nice green flame

 

C.

pH of a 3,3 % aqueous solution

Between 3,8 and 4,8

Purity

 

Peroxides

No colour develops with added KI-solution

Arsenic

Not more than 1 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 285 SODIUM TETRABORATE (BORAX)

Synonyms

Sodium borate

Definition

 

Chemical name

Sodium tetraborate

Sodium biborate

Sodium pyroborate

Anhydrous tetraborate

Einecs

215-540-4

Chemical formula

Na2B4O7

Na2B4O7·10H2O

Molecular weight

201,27

Description

Powder or glass-like plates becoming opaque on exposure to air; slowly soluble in water

Identification

 

A.

Melting range

Between 171 oC and 175 oC with decomposition

Purity

 

Peroxides

No colour develops with added KI-solution

Arsenic

Not more than 1 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 290 CARBON DIOXIDE

Synonyms

Carbonic acid gas

Dry ice (solid form)

Carbonic anhydride

Definition

 

Chemical name

Carbon dioxide

Einecs

204-696-9

Chemical formula

CO2

Molecular weight

44,01

Assay

Content not less than 99 % v/v on the gaseous basis

Description

A colourless gas under normal environmental conditions with a slight pungent odour. Commercial carbon dioxide is shipped and handled as a liquid in pressurised cylinders or bulk storage systems, or in compressed solid blocks of ‘dry ice’. Solid (dry ice) forms usually contain added substances, such as propylene glycol or mineral oil, as binders

Identification

 

A.

Precipitation (Precipitate formation)

When a stream of the sample is passed through a solution of barium hydroxide, a white precipitate is produced which dissolves with effervescence in dilute acetic acid

Purity

 

Acidity

915 ml of gas bubbled through 50 ml of freshly boiled water must not render the latter more acid to methylorange than is 50 ml freshly boiled water to which has been added 1 ml of hydrochloric acid (0,01 N)

Reducing substances, hydrogen phosphide and sulphide

915 ml of gas bubbled through 25 ml of ammoniacal silver nitrate reagent to which has been added 3 ml of ammonia must not cause clouding or blackening of this solution

Carbon monoxide

Not more than 10 μl/l

Oil content

Not more than 0,1 mg/l

E 296 MALIC ACID

Synonyms

DL-Malic acid, pomalous acid

Definition

 

Chemical name

DL-Malic acid, hydroxybutanedioic acid, hydroxysuccinic acid

Einecs

230-022-8

Chemical formula

C4H6O5

Molecular weight

134,09

Assay

Content not less than 99,0 %

Description

White or nearly white crystalline powder or granules

Identification

 

A.

Melting range between 127 oC and 132 oC

 

B.

Positive test for malate

 

C.

Solutions of this substance are optically inactive in all concentrations

 

Purity

 

Sulphated ash

Not more than 0,1 %

Fumaric acid

Not more than 1,0 %

Maleic acid

Not more than 0,05 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 297 FUMARIC ACID

Definition

 

Chemical name

Trans-butenedioic acid, trans-1,2-ethylene-dicarboxylic acid

Einecs

203-743-0

Chemical formula

C4H4O4

Molecular weight

116,07

Assay

Content not less than 99,0 % on the anhydrous basis

Description

White crystalline powder or granules

Identification

 

A.

Melting range

286 oC-302 oC (closed capillary, rapid heating)

B.

Positive tests for double bonds and for 1,2-dicarboxylic acid

 

C.

pH of a 0,05 % solution at 25 oC

3,0-3,2

Purity

 

Loss on drying

Not more than 0,5 % (120 oC, 4h)

Sulphated ash

Not more than 0,1 %

Maleic acid

Not more than 0,1 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 300 ASCORBIC ACID

Definition

 

Chemical name

L-ascorbic acid

Ascorbic acid

2,3-Didehydro-L-threo-hexono-1,4-lactone

3-Keto-L-gulofuranolactone

Einecs

200-066-2

Chemical formula

C6H8O6

Molecular weight

176,13

Assay

Ascorbic acid, after drying in a vacuum desiccator over sulphuric acid for 24 hours, contains not less than 99 % of C6H8O6

Description

White to pale yellow, odourless crystalline solid

Identification

 

A.

Melting range

Between 189 oC and 193 oC with decomposition

B.

Positive tests for ascorbic acid

 

Purity

 

Loss on drying

Not more than 0,4 % after drying in a vacuum desiccator over sulphuric acid for 24 hours

Sulphated ash

Not more than 0,1 %

Specific rotation

[α]D 20 between +20,5o and +21,5o (10 % w/v aqueous solution)

pH of a 2 % aqueous solution

Between 2,4 and 2,8

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 301 SODIUM ASCORBATE

Definition

 

Chemical name

Sodium ascorbate

Sodium L-ascorbate

2,3-Didehydro-L-threo-hexono-1,4-lactone sodium enolate

3-Keto-L-gulofurano-lactone sodium enolate

Einecs

205-126-1

Chemical formula

C6H7O6Na

Molecular weight

198,11

Assay

Sodium ascorbate, after drying in a vacuum desiccator over sulphuric acid for 24 hours, contains not less than 99 % of C6H7O6Na

Description

White or almost white, odourless crystalline solid which darkens on exposure to light

Identification

 

A.

Positive tests for ascorbate and for sodium

 

Purity

 

Loss on drying

Not more than 0,25 % after drying in a vacuum desiccator over sulphuric acid for 24 hours

Specific rotation

[α]D 20 between + 103o and + 106o (10 % w/v aqueous solution)

pH of 10 % aqueous solution

Between 6,5 and 8,0

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 302 CALCIUM ASCORBATE

Definition

 

Chemical name

Calcium ascorbate dihydrate

Calcium salt of 2,3-didehydro-L-threo-hexono-1,4-lactone dihydrate

Einecs

227-261-5

Chemical formula

C12H14O12Ca· 2H2O

Molecular weight

426,35

Assay

Content not less than 98 % on a volatile matter-free basis

Description

White to slightly pale greyish-yellow odourless crystalline powder

Identification

 

A.

Positive tests for ascorbate and for calcium

 

Purity

 

Fluoride

Not more than 10 mg/kg (expressed as fluorine)

Specific rotation

[α]D 20 between + 95o and + 97o (5 % w/v aqueous solution)

pH of 10 % aqueous solution

Between 6,0 and 7,5

Volatile matter

Not more than 0,3 % determined by drying at room temperature for 24 hours in a desiccator containing sulphuric acid or phosphorus pentoxide

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 304 (i) ASCORBYL PALMITATE

Definition

 

Chemical name

Ascorbyl palmitate

L-ascorbyl palmitate

2,3-didehydro-L-threo-hexono-1,4-lactone-6-palmitate

6-palmitoyl-3-keto-L-gulofuranolactone

Einecs

205-305-4

Chemical formula

C22H38O7

Molecular weight

414,55

Assay

Content not less than 98 % on the dried basis

Description

White or yellowish-white solid with a citrus-like odour

Identification

 

A.

Melting range

Between 107 oC and 117 oC

Purity

 

Loss on drying

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

Sulphated ash

Not more than 0,1 %

Specific rotation

[α]D 20 between + 21o and + 24o (5 % w/v in methanol solution)

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 304 (ii) ASCORBYL STEARATE

Definition

 

Chemical name

Ascorbyl stearate

L-ascorbyl stearate

2,3-didehydro-L-threo-hexono-1,4-lactone-6-stearate

6-stearoyl-3-keto-L-gulofuranolactone

Einecs

246-944-9

Chemical formula

C24H42O7

Molecular weight

442,6

Assay

Content not less than 98 %

Description

White or yellowish, white solid with a citrus-like odour

Identification

 

A.

Melting point

About 116 oC

Purity

 

Loss on drying

Not more than 2,0 % after drying in a vacuum oven at 56 oC to 60 oC for one hour

Sulphated ash

Not more than 0,1 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 306 TOCOPHEROL-RICH EXTRACT

Definition

Product obtained by the vacuum steam distillation of edible vegetable oil products, comprising concentrated tocopherols and tocotrienols

Contains tocopherols such as d-α-, d-β-, d-γ- and d-ς-tocopherols

Molecular weight

430,71 (d-α-tocopherol)

Assay

Content not less than 34 % of total tocopherols

Description

Brownish red to red, clear, viscous oil having a mild, characteristic odour and taste. May show a slight separation of wax-like constituents in microcrystalline form

Identification

 

A.

By suitable gas liquid chromatographic method

 

B.

Solubility tests

Insoluble in water. Soluble in ethanol. Miscible in ether

Purity

 

Sulphated ash

Not more than 0,1 %

Specific rotation

[α]D 20 not less than + 20o

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 307 ALPHA-TOCOPHEROL

Synonyms

DL-α-Tocopherol

Definition

 

Chemical name

DL-5,7,8-Trimethyltocol

DL-2,5,7,8-tetramethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol

Einecs

233-466-0

Chemical formula

C29H50O2

Molecular weight

430,71

Assay

Content not less than 96 %

Description

Slightly yellow to amber, nearly odourless, clear, viscous oil which oxidises and darkens on exposure to air or light

Identification

 

A.

Solubility tests

Insoluble in water, freely soluble in ethanol, miscible in ether

B.

Spectro-photometry

In absolute ethanol the maximum absorption is about 292 nm

Purity

 

Refractive index

n D 201,503-1,507

Specific absorption

Formula

in ethanol

Formula(292 nm) 72-76

(0,01 g in 200 ml of absolute ethanol)

Sulphated ash

Not more than 0,1 %

Specific rotation

[α]D 25 0o±0,05o (1 in 10 solution in chloroform)

Lead

Not more than 2 mg/kg

E 308 GAMMA-TOCOPHEROL

Synonyms

dl-γ-Tocopherol

Definition

 

Chemical name

2,7,8-trimethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol

Einecs

231-523-4

Chemical formula

C28H48O2

Molecular weight

416,69

Assay

Content not less than 97 %

Description

Clear, viscous, pale yellow oil which oxidises and darkens on exposure to air or light

Identification

 

A.

Spectrometry

Maximum absorptions in absolute ethanol at about 298 nm and 257 nm

Purity

 

Specific absorption

Formula

in ethanol

Formula

(298 nm) between 91 and 97

Formula

(257 nm) between 5,0 and 8,0

Refractive index

Formula

1,503-1,507

Sulphated ash

Not more than 0,1 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 309 DELTA-TOCOPHEROL

Definition

 

Chemical name

2,8-dimethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol

Einecs

204-299-0

Chemical formula

C27H46O2

Molecular weight

402,7

Assay

Content not less than 97 %

Description

Clear, viscous, pale yellowish or orange oil which oxidises and darkens on exposure to air or light

Identification

 

A.

Spectrometry

Maximum absorptions in absolute ethanol at about 298 nm and 257 nm

Purity

 

Specific absorption

Formula

in ethanol

Formula

(298 nm) between 89 and 95

Formula

(257 nm) between 3,0 and 6,0

Refractive index

Formula

1,500-1,504

Sulphated ash

Not more than 0,1 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 310 PROPYL GALLATE

Definition

 

Chemical name

Propyl gallate

Propyl ester of gallic acid

n-propyl ester of 3,4,5-trihydroxybenzoic acid

Einecs

204-498-2

Chemical formula

C10H12O5

Molecular weight

212,20

Assay

Content not less than 98 % on the anhydrous basis

Description

White to creamy-white, crystalline, odourless solid

Identification

 

A.

Solubility tests

Slightly soluble in water, freely soluble in ethanol, ether and propane-1,2-diol

B.

Melting range

Between 146 oC and 150 oC after drying at 110 oC for four hours

Purity

 

Loss on drying

Not more than 1,0 % (110 oC, four hours)

Sulphated ash

Not more than 0,1 %

Free acid

Not more than 0,5 % (as gallic acid)

Chlorinated organic compound

Not more than 100 mg/kg (as C1)

Specific absorption

Formula

in ethanol

Formula

(275 nm) not less than 485 and not more than 520

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 311 OCTYL GALLATE

Definition

 

Chemical name

Octyl gallate

Octyl ester of gallic acid

n-octyl ester of 3,4,5-trihydroxybenzoic acid

Einecs

213-853-0

Chemical formula

C15H22O5

Molecular weight

282,34

Assay

Content not less than 98 % after drying at 90 oC for six hours

Description

White to creamy-white odourless solid

Identification

 

A.

Solubility tests

Insoluble in water, freely soluble in ethanol, ether and propane-1,2-diol

B.

Melting range

Between 99 oC and 102 oC after drying at 90 oC for six hours

Purity

 

Loss on drying

Not more than 0,5 % (90 oC, six hours)

Sulphated ash

Not more than 0,05 %

Free acid

Not more than 0,5 % (as gallic acid)

Chlorinated organic compound

Not more than 100 mg/kg (as C1)

Specific absorption

Formula

in ethanol

Formula

(275 nm) not less than 375 and not more than 390

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 312 DODECYL GALLATE

Synonyms

Lauryl gallate

Definition

 

Chemical name

Dodecyl gallate

n-dodecyl (or lauryl) ester of 3,4,5-trihydroxybenzoic acid

Dodecyl ester of gallic acid

Einecs

214-620-6

Chemical formula

C19H30O5

Molecular weight

338,45

Assay

Content not less than 98 % after drying at 90 oC for six hours

Description

White or creamy-white odourless solid

Identification

 

A.

Solubility tests

Insoluble in water, freely soluble in ethanol and ether

B.

Melting range

Between 95 oC and 98 oC after drying at 90 oC for six hours

Purity

 

Loss on drying

Not more than 0,5 % (90 oC, six hours)

Sulphated ash

Not more than 0,05 %

Free acid

Not more than 0,5 % (as gallic acid)

Chlorinated organic compound

Not more than 100 mg/kg (as Cl)

Specific absorption

Formula

in ethanol

Formula

(275 nm) not less than 300 and not more than 325

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 30 mg/kg

E 315 ERYTHORBIC ACID

Synonyms

Isoascorbic acid

D-Araboascorbic acid

Definition

 

Chemical name

D-Erythro-hex-2-enoic acid γ-lactone

Isoascorbic acid

D-Isoascorbic acid

Einecs

201-928-0

Chemical formula

C6H8O6

Molecular weight

176,13

Assay

Content not less than 98 % on the anhydrous basis

Description

White to slightly yellow crystalline solid which darkens gradually on exposure to light

Identification

 

A.

Melting range

About 164 oC to 172 oC with decomposition

B.

Positive test for ascorbic acid/colour reaction

 

Purity

 

Loss on drying

Not more than 0,4 % after drying under reduced pressure on silica gel for 3 hours

Sulphated ash

Not more than 0,3 %

Specific rotation

[α]10 % (w/v) aqueous solution between -16,5o to -18,0o

Oxalate

To a solution of 1 g in 10 ml of water add 2 drops of glacial acetic acid and 5 ml of 10 % calcium acetate solution. The solution should remain clear

Lead

Not more than 2 mg/kg

E 316 SODIUM ERYTHORBATE

Synonyms

Sodium isoascorbate

Definition

 

Chemical name

Sodium isoascorbate

Sodium D-isoascorbic acid

Sodium salt of 2,3-didehydro-D-erythro-hexono-1,4-lactone

3-keto-D-gulofurano-lactone sodium enolate monohydrate

Einecs

228-973-9

Chemical formula

C6H7O6Na· H2O

Molecular weight

216,13

Assay

Content not less than 98 % after drying in a vacuum desiccator over sulphuric acid for 24 hours expressed on the monohydrate basis

Description

White crystalline solid

Identification

 

A.

Solubility tests

Freely soluble in water, very slightly soluble in ethanol

B.

Positive test for ascorbic acid/colour reaction

 

C.

Positive test for sodium

 

Purity

 

Loss on drying

Not more than 0,25 % after drying in a vacuum desiccator over sulphuric acid for 24 hours

Specific rotation

[α]10 % (w/v) aqueous solution between + 95o and + 98o

pH of a 10 % aqueous solution

5,5 to 8,0

Oxalate

To a solution of 1 g in 10 ml of water add 2 drops of glacial acetic acid and 5 ml of 10 % calcium acetate solution. The solution should remain clear

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 319 TERTIARY-BUTYLHYDROQUINONE (TBHQ)

Synonyms

TBHQ

Definition

 

Chemical names

Tert-butyl-1,4-benzenediol

2-(1,1-Dimethylethyl)-1,4-benzenediol

Einecs

217-752-2

Chemical formula

C10H14O2

Molecular weight

166,22

Assay

Content not less than 99 % of C10H14O2

Description

White crystalline solid having a characteristic odour

Identification

 

A.

Solubility

Practically insoluble in water; soluble in ethanol

B.

Melting point

Not less than 126,5 oC

C.

Phenolics

Dissolve about 5 mg of the sample in 10 ml of methanol and add 10,5 ml of dimethylamine solution (1 in 4). A red to pink colour is produced

Purity

 

Tertiary-Butyl-p-benzoquinone

Not more than 0,2 %

2,5-Di-tertiary-butyl hydroquinone

Not more than 0,2 %

Hydroxyquinone

Not more than 0,1 %

Toluene

Not more than 25 mg/kg

Lead

Not more than 2 mg/kg

E 320 BUTYLATED HYDROXYANISOLE (BHA)

Synonyms

BHA

Definition

 

Chemical names

3-Tertiary-butyl-4-hydroxyanisole

A mixture of 2-tertiary-butyl-4-hydroxyanisole and 3-tertiary-butyl-4-hydroxyanisole

Einecs

246-563-8

Chemical formula

C11H16O2

Formula weight

180,25

Assay

Content not less than 98,5 % of C11H16O2 and not less than 85 % of 3-tertiary-butyl-4-hydroxyanisole isomer

Description

White or slightly yellow crystals or waxy solid with a slight aromatic smell

Identification

 

A.

Solubility

Insoluble in water, freely soluble in ethanol

B.

Melting range

Between 48 °C and 63 °C

C.

Colour reaction

Passes test for phenol groups

Purity

 

Sulphated ash

Not more than 0,05 % after calcination at 800 ± 25 °C

Phenolic impurities

Not more than 0,5 %

Specific absorption

Formula

Formula

(290 nm) not less than 190 and not more than 210
Specific absorption

Formula

Formula

(228 nm) not less than 326 and not more than 345

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 321 BUTYLATED HYDROXYTOLUENE (BHT)

Synonyms

BHT

Definition

 

Chemical name

2,6-Ditertiary-butyl-p-cresol

4-Methyl-2,6-ditertiarybutylphenol

Einecs

204-881-4

Chemical formula

C15H24O

Molecular weight

220,36

Assay

Content not less than 99 %

Description

White, crystalline or flaked solid, odourless or having a characteristic faint aromatic odour

Identification

 

A.

Solubility tests

Insoluble in water and propane- 1,2-diol

Freely soluble in ethanol

B.

Melting point

At 70 oC

C.

Absorbance maximum

The absorption in the range 230 to 320 nm of a 2 cm layer of a 1 in 100 000 solution in dehydrated ethanol exhibits a maximum only at 278 nm

Purity

 

Sulphated ash

Not more than 0,005 %

Phenolic impurities

Not more than 0,5 %

Specific absorption

Formula

in ethanol

Formula

(278 nm) not less than 81 and not more than 88

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 322 LECITHINS

Synonyms

Phosphatides

Phospholipids

Definition

Lecithins are mixtures or fractions of phosphatides obtained by physical procedures from animal or vegetable foodstuffs; they also include hydrolysed products obtained through the use of harmless and appropriate enzymes. The final product must not show any signs of residual enzyme activity The lecithins may be slightly bleached in aqueous medium by means of hydrogen peroxide. This oxidation must not chemically modify the lecithin phosphatides

Einecs

232-307-2

Assay

Lecithins: not less than 60,0 % of substances insoluble in acetone

Hydrolysed lecithins: not less than 56,0 % of substances insoluble in acetone

Description

Lecithins: brown liquid or viscous semi-liquid or powder

Hydrolysed lecithins: light brown to brown viscous liquid or paste

Identification

 

A.

Positive tests for choline, for phosphorus and fatty acids

 

B.

Test for hydrolysed lecithin

To a 800 ml beaker add 500 ml of water (30 oC-35 oC). Then slowly add 50 ml of the sample with constant stirring. Hydrolysed lecithin will form a homogeneous emulsion. Non-hydrolysed lecithin will form a distinct mass of about 50 g

Purity

 

Loss on drying

Not more than 2,0 % determined by drying at 105 oC for one hour

Toluene-insoluble matter

Not more than 0,3 %

Acid value

Lecithins: not more than 35 mg of potassium hydroxide per gram

Hydrolysed lecithins: not more than 45 mg of potassium hydroxide per gram

Peroxide value

Equal to or less than 10

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 325 SODIUM LACTATE

Definition

 

Chemical name

Sodium lactate

Sodium 2-hydroxypropanoate

Einecs

200-772-0

Chemical formula

C3H5NaO3

Molecular weight

112,06 (anhydrous)

Assay

Content not less than 57 % and not more than 66 %

Description

Colourless, transparent, liquid. Odourless, or with a slight, characteristic odour

Identification

 

A.

Positive test for lactate

 

B.

Positive test for sodium

 

Purity

 

Acidity

Not more than 0,5 % after drying expressed as lactic acid

pH of a 20 % aqueous solution

6,5 to 7,5

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

Reducing substances

No reduction of Fehling's solution

Note:

This specification refers to a 60 % aqueous solution

 

E 326 POTASSIUM LACTATE

Definition

 

Cheminal name

Potassium lactate

Potassium 2-hydroxypropanoate

Einecs

213-631-3

Chemical formula

C3H5O3K

Molecular weight

128,17 (anhydrous)

Assay

Content not less than 57 % and not more than 66 %

Description

Slightly viscous, almost odourless clear liquid. Odourless, or with a slight, characteristic odour

Identification

 

A.

Ignition

Ignite potassium lactate solution to an ash. The ash is alkaline, and an effervescence occurs when acid is added

B.

Colour reaction

Overlay 2 ml of potassium lactate solution on 5 ml of a 1 in 100 solution of catechol in sulphuric acid. A deep red colour is produced at the zone of contact

C.

Positive tests for potassium and for lactate

 

Purity

 

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

Acidity

Dissolve 1 g of potassium lactate solution in 20 ml of water, add 3 drops of phenolphthalein TS and titrate with 0,1 N sodium hydroxide. Not more than 0,2 ml should be required

Reducing substances

Potassium lactate solution shall not cause any reduction of Fehling's solution

Note:

This specification refers to a 60 % aqueous solution

 

E 327 CALCIUM LACTATE

Definition

 

Chemical name

Calcium dilactate

Calcium dilactate hydrate

2-Hydroxypropanoic acid calcium salt

Einecs

212-406-7

Chemical formula

(C3H5O2)2 Ca· nH2O (n = 0-5)

Molecular weight

218,22 (anhydrous)

Assay

Content not less than 98 % on the anhydrous basis

Description

Almost odourless, white crystalline powder or granules

Identification

 

A.

Positive tests for lactate and for calcium

 

B.

Solubility tests

Soluble in water and practically insoluble in ethanol

Purity

 

Loss on drying

Determined by drying at 120 oC for four hours:

anhydrous: not more than 3,0 %

with 1 molecule of water: not more than 8,0 %

with 3 molecules of water: not more than 20,0 %

with 4,5 molecules of water: not more than 27,0 %

Acidity

Not more than 0,5 % of the dry matter expressed as lactic acid

Fluoride

Not more than 30 mg/kg (expressed as fluorine)

pH of a 5 % solution

Between 6,0 and 8,0

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

Reducing substances

No reduction of Fehling's solution

E 330 CITRIC ACID

Definition

 

Chemical name

Citric acid

2-Hydroxy-1,2,3-propanetricarboxylic acid

β-Hydroxytricarballytic acid

Einecs

201-069-1

Chemical formula

(a)

C6H8O7 (anhydrous)

(b)

C6H8O7·H2O (monohydrate)

Molecular weight

(a)

192,13 (anhydrous)

(b)

210,15 (monohydrate)

Assay

Citric acid may be anhydrous or it may contain 1 molecule of water. Citric acid contains not less than 99,5 % of C6H8O7, calculated on the anhydrous basis

Description

Citric acid is a white or colourless, odourless, crystalline solid, having a strongly acid taste. The monohydrate effloresces in dry air

Identification

 

A.

Solubility tests

Very soluble in water; freely soluble in ethanol; soluble in ether

Purity

 

Water content

Anhydrous citric acid contains not more than 0,5 % water; citric acid monohydrate contains not more than 8,8 % water (Karl Fischer method)

Sulphated ash

Not more than 0,05 % after calcination at 800 ± 25 oC

Arsenic

Not more than 1 mg/kg

Lead

Not more than 1 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 5 mg/kg

Oxalates

Not more than 100 mg/kg, expressed as oxalic acid, after drying

Readily carbonisable substances

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

E 331 (i) MONOSODIUM CITRATE

Synonyms

Monosodium citrate

Monobasic sodium citrate

Definition

 

Chemical name

Monosodium citrate

Monosodium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid

Chemical formula

(a)

C6H7O7Na (anhydrous)

(b)

C6H7O7Na· H2O (monohydrate)

Molecular weight

(a)

214,11 (anhydrous)

(b)

232,23 (monohydrate)

Assay

Content not less than 99 % on the anhydrous basis

Description

Crystalline white powder or colourless crystals

Identification

 

A.

Positive tests for citrate and for sodium

 

Purity

 

Loss on drying

Determined by drying at 180 oC for four hours:

anhydrous: not more than 1,0 %

monohydrate: not more than 8,8 %

Oxalates

Not more than 100 mg/kg expressed as oxalic acid, after drying

pH of a 1 % aqueous solution

Between 3,5 and 3,8

Arsenic

Not more than 1 mg/kg

Lead

Not more than 1 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 5 mg/kg

E 331 (ii) DISODIUM CITRATE

Synonyms

Disodium citrate

Dibasic sodium citrate

Definition

 

Chemical name

Disodium citrate

Disodium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid

Disodium salt of citric acid with 1,5 molecules of water

Einecs

205-623-3

Chemical formula

C6H6O7Na2·1,5H2O

Molecular weight

263,11

Assay

Content not less than 99 % on the anhydrous basis

Description

Crystalline white powder or colourless crystals

Identification

 

A.

Positive tests for citrate and for sodium

 

Purity

 

Loss on drying

Not more than 13,0 % by drying at 180 oC for four hours

Oxalates

Not more than 100 mg/kg expressed as oxalic acid, after drying

pH of a 1 % aqueous solution

Between 4,9 and 5,2

Arsenic

Not more than 1 mg/kg

Lead

Not more than 1 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 5 mg/kg

E 331 (iii) TRISODIUM CITRATE

Synonyms

Trisodium citrate

Tribasic sodium citrate

Definition

 

Chemical name

Trisodium citrate

Trisodium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid

Trisodium salt of citric acid, in anhydrous, dihydrate or pentahydrate form

Einecs

200-675-3

Chemical formula

Anhydrous:

C6H5O7Na3

Hydrated:

C6H5O7Na3·nH2O (n = 2 or 5)

Molecular weight

258,07 (anhydrous)

Assay

Not less than 99 % on the anhydrous basis

Description

Crystalline white powder or colourless crystals

Identification

 

A.

Positive tests for citrate and for sodium

 

Purity

 

Loss on drying

Determined by drying at 180 oC for four hours:

anhydrous:

not more than 1,0 %

dihydrate:

not more than 13,5 %

pentahydrate:

not more than 30,3 %

Oxalates

Not more than 100 mg/kg expressed as oxalic acid, after drying

pH of a 5 % aqueous solution

Between 7,5 and 9,0

Arsenic

Not more than 1 mg/kg

Lead

Not more than 1 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 5 mg/kg

E 332 (i) MONOPOTASSIUM CITRATE

Synonyms

Monopotassium citrate

Monobasic potassium citrate

Definition

 

Chemical name

Monopotassium citrate

Monopotassium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid

Anhydrous monopotassium salt of citric acid

Einecs

212-753-4

Chemical formula

C6H7O7K

Molecular weight

230,21

Assay

Content not less than 99 % on the anhydrous basis

Description

White, hygroscopic, granular powder or transparent crystals

Identification

 

A.

Positive tests for citrate and for potassium

 

Purity

 

Loss on drying

Not more than 1,0 % determined by drying at 180 oC for four hours

Oxalates

Not more than 100 mg/kg expressed as oxalic acid, after drying

pH of a 1 % aqueous solution

Between 3,5 and 3,8

Arsenic

Not more than 1 mg/kg

Lead

Not more than 1 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 5 mg/kg

E 332 (ii) TRIPOTASSIUM CITRATE

Synonyms

Tripotassium citrate

Tribasic potassium citrate

Definition

 

Chemical name

Tripotassium citrate

Tripotassium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid

Monohydrated tripotassium salt of citric acid

Einecs

212-755-5

Chemical formula

C6H5O7K3·H2O

Molecular weight

324,42

Assay

Content not less than 99 % on the anhydrous basis

Description

White, hygroscopic, granular powder or transparent crystals

Identification

 

A.

Positive tests for citrate and for potassium

 

Purity

 

Loss on drying

Not more than 6,0 % determined by drying at 180 oC for four hours

Oxalates

Not more than 100 mg/kg expressed as oxalic acid, after drying

pH of a 5 % aqueous solution

Between 7,5 and 9,0

Arsenic

Not more than 1 mg/kg

Lead

Not more than 1 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 5 mg/kg

E 333 (i) MONOCALCIUM CITRATE

Synonyms

Monocalcium citrate

Monobasic calcium citrate

Definition

 

Chemical name

Monocalcium citrate

Monocalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid

Monohydrate monocalcium salt of citric acid

Chemical formula

(C6H7O7)2Ca· H2O

Molecular weight

440,32

Assay

Content not less than 97,5 % on the anhydrous basis

Description

Fine white powder

Identification

 

A.

Positive tests for citrate and for calcium

 

Purity

 

Loss on drying

Not more than 7,0 % determined by drying at 180 oC for four hours

Oxalates

Not more than 100 mg/kg expressed as oxalic acid, after drying

pH of a 1 % aqueous solution

Between 3,2 and 3,5

Fluoride

Not more than 30 mg/kg (expressed as fluorine)

Arsenic

Not more than 1 mg/kg

Lead

Not more than 1 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 5 mg/kg

Carbonates

Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must not liberate more than a few isolated bubbles

E 333 (ii) DICALCIUM CITRATE

Synonyms

Dicalcium citrate

Dibasic calcium citrate

Definition

 

Chemical name

Dicalcium citrate

Dicalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid

Trihydrated dicalcium salt of citric acid

Chemical formula

(C6H7O7)2Ca2·3H2O

Molecular weight

530,42

Assay

Not less than 97,5 % on the anhydrous basis

Description

Fine white powder

Identification

 

A.

Positive tests for citrate and for calcium

 

Purity

 

Loss on drying

Not more than 20,0 % determined by drying at 180 oC for four hours

Oxalates

Not more than 100 mg/kg expressed as oxalic acid, after drying

Fluoride

Not more than 30 mg/kg (expressed as fluorine)

Arsenic

Not more than 1 mg/kg

Lead

Not more than 1 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 5 mg/kg

Carbonates

Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must not liberate more than a few isolated bubbles

E 333 (iii) TRICALCIUM CITRATE

Synonyms

Tricalcium citrate

Tribasic calcium citrate

Definition

 

Chemical name

Tricalcium citrate

Tricalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid

Tetrahydrated tricalcium salt of citric acid

Einecs

212-391-7

Chemical formula

(C6H6O7)2Ca3·4H2O

Molecular weight

570,51

Assay

Not less than 97,5 % on the anhydrous basis

Description

Fine white powder

Identification

 

A.

Positive tests for citrate and for calcium

 

Purity

 

Loss on drying

Not more than 14,0 % determined by drying at 180 oC for four hours

Oxalates

Not more than 100 mg/kg expressed as oxalic acid, after drying

Fluoride

Not more than 30 mg/kg (expressed as fluorine)

Arsenic

Not more than 1 mg/kg

Lead

Not more than 1 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 5 mg/kg

Carbonates

Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must not liberate more than a few isolated bubbles

E 334 L(+)-TARTARIC ACID

Definition

 

Chemical name

L-tartaric acid

L-2,3-dihydroxybutanedioic acid

d-α, β-dihydroxysuccinic acid

Einecs

201-766-0

Chemical formula

C4H6O6

Molecular weight

150,09

Assay

Content not less than 99,5 % on the anhydrous basis

Description

Colourless or translucent crystalline solid or white crystalline powder

Identification

 

A.

Melting range

Between 168 oC and 170 oC

B.

Positive test for tartrate

 

Purity

 

Loss on drying

Not more than 0,5 % (over P2O5, three hours)

Sulphated ash

Not more than 1 000 mg/kg after calcination at 800 ± 25 oC

Specific optical rotation of a 20 % w/v aqueous solution

[α] 20 D between +11,5o and +13,5o

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

Oxalates

Not more than 100 mg/kg expressed as oxalic acid, after drying

E 335 (i) MONOSODIUM TARTRATE

Synonyms

Monosodium salt of L-(+)-tartaric acid

Definition

 

Chemical name

Monosodium salt of L-2,3-dihydroxybutanedioic acid

Monohydrated monosodium salt of L-(+)-tartaric acid

Chemical formula

C4H5O6Na· H2O

Molecular weight

194,05

Assay

Content not less than 99 % on the anhydrous basis

Description

Transparent colourless crystals

Identification

 

A.

Positive tests for tartrate and for sodium

 

Purity

 

Loss on drying

Not more than 10,0 % determined by drying at 105 oC for four hours

Oxalates

Not more than 100 mg/kg expressed as oxalic acid, after drying

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 335 (ii) DISODIUM TARTRATE

Definition

 

Chemical name

Disodium L-tartrate

Disodium (+)-tartrate

Disodium (+)-2,3-dihydroxybutanedioic acid

Dihydrated disodium salt of L-(+)-tartaric acid

Einecs

212-773-3

Chemical formula

C4H4O6Na2·2H2O

Molecular weight

230,8

Assay

Content not less than 99 % on the anhydrous basis

Description

Transparent, colourless crystals

Identification

 

A.

Positive tests for tartrate and for sodium

 

B.

Solubility tests

1 gram is insoluble in 3 ml of water. Insoluble in ethanol

Purity

 

Loss on drying

Not more than 17,0 % determined by drying at 150 oC for four hours

Oxalates

Not more than 100 mg/kg expressed as oxalic acid, after drying

pH of a 1 % aqueous solution

Between 7,0 and 7,5

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 336 (i) MONOPOTASSIUM TARTRATE

Synonyms

Monobasic potassium tartrate

Definition

 

Chemical name

Anhydrous monopotassium salt of L-(+)-tartaric acid

Monopotassium salt of L-2,3-dihydroxybutanedioic acid

Chemical formula

C4H5O6K

Molecular weight

188,16

Assay

Content not less than 98 % on the anhydrous basis

Description

White crystalline or granulated powder

Identification

 

A.

Positive tests for tartrate and for potassium

 

B.

Melting point

230 oC

Purity

 

pH of a 1 % aqueous solution

3,4

Loss on drying

Not more than 1,0 % determined by drying at 105 oC for four hours

Oxalates

Not more than 100 mg/kg expressed as oxalic acid, after drying

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 336 (ii) DIPOTASSIUM TARTRATE

Synonyms

Dibasic potassium tartrate

Definition

 

Chemical name

Dipotassium salt of L-2,3-dihydroxybutanedioic acid

Dipotassium salt with half a molecule of water of L-(+)-tartaric acid

Einecs

213-067-8

Chemical formula

C4H4O6K2·1/2H2O

Molecular weight

235,2

Assay

Content not less than 99 % on the anhydrous basis

Description

White crystalline or granulated powder

Identification

 

A.

Positive tests for tartrate and for potassium

 

Purity

 

pH of a 1 % aqueous solution

Between 7,0 and 9,0

Loss on drying

Not more than 4,0 % determined by drying at 150 oC for four hours

Oxalates

Not more than 100 mg/kg expressed as oxalic acid, after drying

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 337 POTASSIUM SODIUM TARTRATE

Synonyms

Potassium sodium L-(+)-tartrate

Rochelle salt

Seignette salt

Definition

 

Chemical name

Potassium sodium salt of L-2,3-dihydroxybutanedioic acid

Potassium sodium L-(+)-tartrate

Einecs

206-156-8

Chemical formula

C4H4O6KNa· 4H2O

Molecular weight

282,23

Assay

Content not less than 99 % on the anhydrous basis

Description

Colourless crystals or white crystalline powder

Identification

 

A.

Positive tests for tartrate, for potassium and for sodium

 

B.

Solubility tests

1 gram is soluble in 1 ml of water, insoluble in ethanol

C.

Melting range

Between 70 and 80 oC

Purity

 

Loss on drying

Not more than 26,0 % and not less than 21,0 % determined by drying at 150 oC for three hours

Oxalates

Not more than 100 mg/kg expressed as oxalic acid, after drying

pH of 1 % aqueous solution

Between 6,5 and 8,5

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 338 PHOSPHORIC ACID

Synonyms

Orthophosphoric acid

Monophosphoric acid

Definition

 

Chemical name

Phosphoric acid

Einecs

231-633-2

Chemical formula

H3PO4

Molecular weight

98,00

Assay

Phosphoric acid is commercially available as an aqueous solution at variable concentrations. Content not less than 67,0 % and not more than 85,7 %.

Description

Clear, colourless, viscous liquid

Identification

 

A.

Positive tests for acid and for phosphate

 

Purity

 

Volatile acids

Not more than 10 mg/kg (as acetic acid)

Chlorides

Not more than 200 mg/kg (expressed as chlorine)

Nitrates

Not more than 5 mg/kg (as NaNO3)

Sulphates

Not more than 1 500 mg/kg (as CaSO4)

Fluoride

Not more than 10 mg/kg (expressed as fluorine)

Arsenic

Not more than 3 mg/kg

Cadmium

Not more than 1 mg/kg

Lead

Not more than 4 mg/kg

Mercury

Not more than 1 mg/kg

Note:

This specification refers to a 75 % aqueous solution

 

E 339 (i) MONOSODIUM PHOSPHATE

Synonyms

Monosodium monophosphate

Acid monosodium monophosphate

Monosodium orthophosphate

Monobasic sodium phosphate

Sodium dihydrogen monophosphate

Definition

 

Chemical name

Sodium dihydrogen monophosphate

Einecs

231-449-2

Chemical formula

Anhydrous: NaH2PO4

Monohydrate: NaH2PO4 · H2O

Dihydrate: NaH2PO4 · 2H2O

Molecular weight

Anhydrous: 119,98

Monohydrate: 138,00

Dihydrate: 156,01

Assay

After drying at 60 oC for one hour and then at 105 oC for four hours, contains not less than 97 % of NaH2PO4

P2O5 content

Between 58,0 % and 60,0 % on the anhydrous basis

Description

A white odourless, slightly deliquescent powder, crystals or granules

Identification

 

A.

Positive tests for sodium and for phosphate

 

B.

Solubility

Freely soluble in water. Insoluble in ethanol or ether

C.

pH of a 1 % solution

Between 4,1 and 5,0

Purity

 

Loss on drying

The anhydrous salt loses not more than 2,0 %, the monohydrate not more than 15,0 %, and the dihydrate not more than 25 % when dried first at 60 oC for one hour, then at 105 oC for four hours

Water-insoluble substances

Not more than 0,2 % on the anhydrous basis

Fluoride

Not more than 10 mg/kg (expressed as fluorine)

Arsenic

Not more than 3 mg/kg

Cadmium

Not more than 1 mg/kg

Lead

Not more than 4 mg/kg

Mercury

Not more than 1 mg/kg

E 339 (ii) DISODIUM PHOSPHATE

Synonyms

Disodium monophosphate

Secondary sodium phosphate

Disodium orthophosphate

Acid disodium phosphate

Definition

 

Chemical name

Disodium hydrogen monophosphate

Disodium hydrogen orthophosphate

Einecs

231-448-7

Chemical formula

Anhydrous: Na2HPO4

Hydrat: Na2HPO4 · nH2O (n = 2,7 or 12)

Molecular weight

141,98 (anhydrous)

Assay

After drying at 40 oC for three hours and subsequently at 105 oC for five hours, contains not less than 98 % of Na2HPO4

P2O5 content

Between 49 % and 51 % on the anhydrous basis

Description

Anhydrous disodium hydrogen phosphate is a white, hygroscopic, odourless powder. Hydrated forms available include the dihydrate: a white crystalline, odourless solid; the heptahydrate: white, odourless, efflorescent crystals or granular powder; and the dodecahydrate: white, efflorescent, odourless powder or crystals

Identification

 

A.

Positive tests for sodium and for phosphate

 

B.

Solubility

Freely soluble in water. Insoluble in ethanol

C.

pH of a 1 % solution

Between 8,4 and 9,6

Purity

 

Loss on drying

When dried at 40 oC for three hours and then at 105 oC for five hours, the losses in weight are as follows: anhydrous not more than 5,0 %, dihydrate not more than 22,0 %, heptahydrate not more than 50,0 %, dodecahydrate not more than 61,0 %

Water-insoluble substances

Not more than 0,2 % on the anhydrous basis

Fluoride

Not more than 10 mg/kg (expressed as fluorine)

Arsenic

Not more than 3 mg/kg

Cadmium

Not more than 1 mg/kg

Lead

Not more than 4 mg/kg

Mercury

Not more than 1 mg/kg

E 339 (iii) TRISODIUM PHOSPHATE

Synonyms

Sodium phosphate

Tribasic sodium phosphate

Trisodium orthophosphate

Definition

Trisodium phosphate is obtained from aqueous solutions and crystallises in the anhydrous form and with 1/2, 1, 6, 8 or 12 H2O. The dodecahydrate always crystallises from aqueous solutions with an excess of sodium hydroxide. It contains 1/4 molecule of NaOH

Chemical name

Trisodium monophosphate

Trisodium phosphate

Trisodium orthophosphate

Einecs

231-509-8

Chemical formula

Anhydrous: Na3PO4

Hydrated: Na3PO4 · nH2O (n = 1/2, 1, 6, 8, or 12)

Molecular weight

163,94 (anhydrous)

Assay

Sodium phosphate anhydrous and the hydrated forms, with the exception of the dodecahydrate, contain not less than 97,0 % of Na3PO4 calculated on the dried basis. Sodium phosphate dodecahydrate contains not less than 92,0 % of Na3PO4 calculated on the ignited basis

P2O5 content

Between 40,5 % and 43,5 % on the anhydrous basis

Description

White odourless crystals, granules or crystalline powder

Identification

 

A.

Positive tests for sodium and for phosphate

 

B.

Solubility

Freely soluble in water. Insoluble in ethanol

C.

pH of a 1 % solution

Between 11,5 and 12,5

Purity

 

Loss on ignition

When dried at 120 oC for two hours and then ignited at about 800 oC for 30 minutes, the losses in weight are as follows: anhydrous not more than 2,0 %, monohydrate not more than 11,0 %, dodecahydrate: between 45,0 % and 58,0 %

Water insoluble substances

Not more than 0,2 % on the anhydrous basis

Fluoride

Not more than 10 mg/kg (expressed as fluorine)

Arsenic

Not more than 3 mg/kg

Cadmium

Not more than 1 mg/kg

Lead

Not more than 4 mg/kg

Mercury

Not more than 1 mg/kg

E 340 (i) MONOPOTASSIUM PHOSPHATE

Synonyms

Monobasic potassium phosphate

Monopotassium monophosphate

Potassium orthophosphate

Definition

 

Chemical name

Potassium dihydrogen phosphate

Monopotassium dihydrogen orthophosphate

Monopotassium dihydrogen monophosphate

Einecs

231-913-4

Chemical formula

KH2PO4

Molecular weight

136,09

Assay

Content not less than 98,0 % after drying at 105 oC for four hours

P2O5 content

Between 51,0 % and 53,0 % on the anhydrous basis

Description

Odourless, colourless crystals or white granular or crystalline powder, hygroscopic

Identification

 

A.

Positive tests for potassium and for phosphate

 

B.

Solubility

Freely soluble in water. Insoluble in ethanol

C.

pH of a 1 % solution

Between 4,2 and 4,8

Purity

 

Loss on drying

Not more than 2,0 % determined by drying at 105 oC for four hours

Water-insoluble substances

Not more than 0,2 % on the anhydrous basis

Fluoride

Not more than 10 mg/kg (expressed as fluorine)

Arsenic

Not more than 3 mg/kg

Cadmium

Not more than 1 mg/kg

Lead

Not more than 4 mg/kg

Mercury

Not more than 1 mg/kg

E 340 (ii) DIPOTASSIUM PHOSPHATE

Synonyms

Dipotassium monophosphate

Secondary potassium phosphate

Dipotassium acid phosphate

Dipotassium orthophosphate

Dibasic potassium phosphate

Definition

 

Chemical name

Dipotassium hydrogen monophosphate

Dipotassium hydrogen phosphate

Dipotassium hydrogen orthophosphate

Einecs

231-834-5

Chemical formula

K2HPO4

Molecular weight

174,18

Assay

Content not less than 98 % after drying at 105 oC for four hours

P2O5 content

Between 40,3 % and 41,5 % on the anhydrous basis

Description

Colourless or white granular powder, crystals or masses; deliquescent substance

Identification

 

A.

Positive tests for potassium and for phosphate

 

B.

Solubility

Freely soluble in water. Insoluble in ethanol

C.

pH of a 1 % solution

Between 8,7 and 9,4

Purity

 

Loss on drying

Not more than 2,0 % determined by drying at 105 oC for four hours

Water-insoluble substances

Not more than 0,2 % on the anhydrous basis

Fluoride

Not more than 10 mg/kg (expressed as fluorine)

Arsenic

Not more than 3 mg/kg

Cadmium

Not more than 1 mg/kg

Lead

Not more than 4 mg/kg

Mercury

Not more than 1 mg/kg

E 340 (iii) TRIPOTASSIUM PHOSPHATE

Synonyms

Potassium phosphate

Tribasic potassium phosphate

Tripotassium orthophosphate

Definition

 

Chemical name

Tripotassium monophosphate

Tripotassium phosphate

Tripotassium orthophosphate

Einecs

231-907-1

Chemical formula

Anhydrous: K3PO4

Hydrated: K3PO4 · nH2O (n = 1 or 3)

Molecular weight

212,27 (anhydrous)

Assay

Content not less than 97 % calculated on the ignited basis

P2O5 content

Between 30,5 % and 33,0 % on the ignited basis

Description

Colourless or white, odourless hygroscopic crystals or granules. Hydrated forms available include the monohydrate and trihydrate

Identification

 

A.

Positive tests for potassium and for phosphate

 

B.

Solubility

Freely soluble in water. Insoluble in ethanol

C.

pH of a 1 % solution

Between 11,5 and 12,3

Purity

 

Loss on ignition

Anhydrous: not more than 3,0 %; hydrated: not more than 23,0 %. Determined by drying at 105 oC for one hour and then ignite at about 800 oC ± 25 oC for 30 minutes

Water insoluble substances

Not more than 0,2 % on the anhydrous basis

Fluoride

Not more than 10 mg/kg (expressed as fluorine)

Arsenic

Not more than 3 mg/kg

Cadmium

Not more than 1 mg/kg

Lead

Not more than 4 mg/kg

Mercury

Not more than 1 mg/kg

E 341 (i) MONOCALCIUM PHOSPHATE

Synonyms

Monobasic calcium phosphate

Monocalcium orthophosphate

Definition

 

Chemical name

Calcium dihydrogen phosphate

Einecs

231-837-1

Chemical formula

Anhydrous: Ca(H2PO4)2

Monohydrate: Ca(H2PO4)2 · H2O

Molecular weight

234,05 (anhydrous)

252,08 (monohydrate)

Assay

Content not less than 95 % on the dried basis

P2O5 content

Between 55,5 % and 61,1 % on the anhydrous basis

Description

Granular powder or white, deliquescent crystals or granules

Identification

 

A.

Positive tests for calcium and for phosphate

 

B.

CaO content

Between 23,0 % and 27,5 % (anhydrous)

Between 19,0 % and 24,8 % (monohydrate)

Purity

 

Loss on drying

Not more than 14 % determined by drying at 105 oC for four hours (anhydrous)

Not more than 17,5 % determined by drying at 60 oC for one hour, then at 105 oC for four hours (monohydrate)

Loss on ignition

Not more than 17,5 % after ignition at 800 oC ± 25 oC for 30 minutes (anhydrous)

Not more than 25,0 % determined by drying at 105 oC for one hour, then ignite at 800 oC ± 25 oC for 30 minutes (monohydrate)

Fluoride

Not more than 30 mg/kg (expressed as fluorine)

Arsenic

Not more than 3 mg/kg

Cadmium

Not more than 1 mg/kg

Lead

Not more than 4 mg/kg

Mercury

Not more than 1 mg/kg

E 341 (ii) DICALCIUM PHOSPHATE

Synonyms

Dibasic calcium phosphate

Dicalcium orthophosphate

Definition

 

Chemical name

Calcium monohydrogen phosphate

Calcium hydrogen orthophosphate

Secondary calcium phosphate

Einecs

231-826-1

Chemical formula

Anhydrous: CaHPO4

Dihydrate: CaHPO4 · 2H2O

Molecular weight

136,06 (anhydrous)

172,09 (dihydrate)

Assay

Dicalcium phosphate, after drying at 200 oC for three hours, contains not less than 98 % and not more than the equivalent of 102 % of CaHPO4

P2O5 content

Between 50,0 % and 52,5 % on the anhydrous basis

Description

White crystals or granules, granular powder or powder

Identification

 

A.

Positive tests for calcium and for phosphate

 

B.

Solubility tests

Sparingly soluble in water. Insoluble in ethanol

Purity

 

Loss on ignition

Not more than 8,5 % (anhydrous), or 26,5 % (dihydrate) after ignition at 800 oC ± 25 oC for 30 minutes

Fluoride

Not more than 50 mg/kg (expressed as fluorine)

Arsenic

Not more than 3 mg/kg

Cadmium

Not more than 1 mg/kg

Lead

Not more than 4 mg/kg

Mercury

Not more than 1 mg/kg

E 341 (iii) TRICALCIUM PHOSPHATE

Synonyms

Calcium phosphate, tribasic

Calcium orthophosphate

Pentacalcium hydroxy monophosphate

Calcium hydroxyapatite

Definition

Tricalcium phosphate consists of a variable mixture of calcium phosphates obtained from neutralisation of phosphoric acid with calcium hydroxide and having the approximate composition of 10CaO · 3P2O5 · H2O

Chemical name

Pentacalcium hydroxy monophosphate

Tricalcium monophosphate

Einecs

235-330-6 (Pentacalcium hydroxy monophosphate)

231-840-8 (Calcium orthophosphate)

Chemical formula

Ca5(PO4)3· OH or Ca3(PO4)2

Molecular weight

502 or 310

Assay

Content not less than 90 % calculated on the ignited basis

P2O5 content

Between 38,5 % and 48,0 % on the anhydrous basis

Description

A white, odourless powder which is stable in air

Identification

 

A.

Positive tests for calcium and for phosphate

 

B.

Solubility

Practically insoluble in water; insoluble in ethanol soluble in dilute hydrochloric and nitric acid

Purity

 

Loss on ignition

Not more than 8 % after ignition at 800 oC ± 25 oC, to constant weight

Fluoride

Not more than 50 mg/kg (expressed as fluorine)

Arsenic

Not more than 3 mg/kg

Cadmium

Not more than 1 mg/kg

Lead

Not more than 4 mg/kg

Mercury

Not more than 1 mg/kg

E 343(i) MONOMAGNESIUM PHOSPHATE

Synonyms

Magnesiumdihydrogenphosphate

Magnesiumphosphate, monobasic

Monomagnesium orthophosphate

Definition

 

Chemical name

Monomagnesiumdihydrogenmonophosphate

Einecs

236-004-6

Chemical formula

Mg(H2PO4)2 · nH2O (where n = 0 to 4)

Molecular weight

218,30 (anhydrous)

Assay

Not less than 51,0 % after ignition

Description

White, odourless, crystalline powder, slightly soluble in water

Identification

 

A.

Positive test for magnesium and for phosphate

 

B.

MgO content

Not less than 21,5 % after ignition

Purity

 

Fluoride

Not more than 10 mg/kg (as fluorine)

Arsenic

Not more than 3 mg/kg

Lead

Not more than 4 mg/kg

Cadmium

Not more than 1 mg/kg

Mercury

Not more than 1 mg/kg

E 343(ii) DIMAGNESIUM PHOSPHATE

Synonyms

Magnesiumhydrogenphosphate

Magnesiumphosphate, dibasic

Dimagnesium orthophosphate

Secondary magnesiumphosphate

Definition

 

Chemical name

Dimagnesiummonohydrogenmonophosphate

Einecs

231-823-5

Chemical formula

MgHPO4 · nH2O (where n = 0-3)

Molecular weight

120,30 (anhydrous)

Assay

Not less than 96 % after ignition

Description

White, odourless, crystalline powder, slightly soluble in water

Identification

 

A.

Positive test for magnesium and for phosphate

 

B.

MgO content:

Not less than 33,0 % calculated on an anhydrous basis

Purity

 

Fluoride

Not more than 10 mg/kg (as fluorine)

Arsenic

Not more than 3 mg/kg

Lead

Not more than 4 mg/kg

Cadmium

Not more than 1 mg/kg

Mercury

Not more than 1 mg/kg

E 350 (i) SODIUM MALATE

Synonyms

Sodium salt of malic acid

Definition

 

Chemical name

Disodium DL-malate, disodium salt of hydroxybutanedioic acid

Chemical formula

Hemihydrate: C4H4Na2O5 · 1/2 H2O

Trihydrate: C4H4Na2O5 · 3H2O

Molecular weight

Hemihydrate: 187,05

Trihydrate: 232,10

Assay

Content not less than 98,0 % on the anhydrous basis

Description

White crystalline powder or lumps

Identification

 

A.

Positive tests for 1,2-dicarboxylic acid and for sodium

 

B.

Azo dye formation

Positive

C.

Solubility

Freely soluble in water

Purity

 

Loss on drying

Not more than 7,0 % (130 oC, 4h) for the hemihydrate, or 20,5 %-23,5 % (130 oC, 4h) for the trihydrate

Alkalinity

Not more than 0,2 % as Na2CO3

Fumaric acid

Not more than 1,0 %

Maleic acid

Not more than 0,05 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 350 (ii) SODIUM HYDROGEN MALATE

Synonyms

Monosodium salt of DL-malic acid

Definition

 

Chemical name

Monosodium DL-malate, monosodium 2-DL-hydroxy succinate

Chemical formula

C4H5NaO5

Molecular weight

156,07

Assay

Content not less than 99,0 % on the anhydrous basis

Description

White powder

Identification

 

A.

Positive tests for 1,2-dicarboxylic acid and for sodium

 

B.

Azo dye formation

Positive

Purity

 

Loss on drying

Not more than 2,0 % (110 oC, 3h)

Maleic acid

Not more than 0,05 %

Fumaric acid

Not more than 1,0 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 351 POTASSIUM MALATE

Synonyms

Potassium salt of malic acid

Definition

 

Chemical name

Dipotassium DL-malate, dipotassium salt of hydroxybutanedioic acid

Chemical formula

C4H4K2O5

Molecular weight

210,27

Assay

Content not less than 59,5 %

Description

Colourless or almost colourless aqueous solution

Identification

 

A.

Positive tests for 1,2-dicarboxylic acid and for potassium

 

B.

Azo dye formation

Positive

Purity

 

Alkalinity

Not more than 0,2 % as K2CO3

Fumaric acid

Not more than 1,0 %

Maleic acid

Not more than 0,05 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 352 (i) CALCIUM MALATE

Synonyms

Calcium salt of malic acid

Definition

 

Chemical name

Calcium DL-malate, calcium-α-hydroxysuccinate, calcium salt of hydroxybutanedioic acid

Chemical formula

C4H5CaO5

Molecular weight

172,14

Assay

Content not less than 97,5 % on the anhydrous basis

Description

White powder

Identification

 

A.

Positive tests for malate, 1,2-dicarboxylic acid and for calcium

 

B.

Azo dye formation

Positive

C.

Solubility

Slightly soluble in water

Purity

 

Loss on drying

Not more than 2 % (100 oC, 3h)

Alkalinity

Not more than 0,2 % as CaCO3

Maleic acid

Not more than 0,05 %

Fumaric acid

Not more than 1,0 %

Fluoride

Not more than 30 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 352 (ii) CALCIUM HYDROGEN MALATE

Synonyms

Monocalcium salt of DL-malic acid

Definition

 

Chemical name

Monocalcium DL-malate, monocalcium 2-DL-hydroxysuccinate

Chemical formula

(C4H5O5)2Ca

Assay

Content not less than 97,5 % on the anhydrous basis

Description

White powder

Identification

 

A.

Positive tests for 1,2-dicarboxylic acid and for calcium

 

B.

Azo dye formation

Positive

Purity

 

Loss on drying

Not more than 2,0 % (110 oC, 3h)

Maleic acid

Not more than 0,05 %

Fumaric acid

Not more than 1,0 %

Fluoride

Not more than 30 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 353 METATARTARIC ACID

Synonyms

Ditartaric acid

Definition

 

Chemical name

Metatartaric acid

Chemical formula

C4H6O6

Assay

Not less than 99,5 %

Description

Crystalline or powder form with a white or yellowish colour. Very deliquescent with a faint odour of caramel

Identification

 

A.

Very soluble in water and ethanol

B.

Place a sample of 1 to 10 mg of this substance in a test tube with 2 ml of concentrated sulfuric acid and 2 drops of sulpho-resorcinol reagent. When heated to 150 oC, an intense violet coloration appears

Purity

 

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 354 CALCIUM TARTRATE

Synonyms

L-Calcium tartrate

Definition

 

Chemical name

Calcium L(+)-2,3-dihydroxybutanedioate di-hydrate

Chemical formula

C4H4CaO6 · 2H2O

Molecular weight

224,18

Assay

Not less than 98,0 %

Description

Fine crystalline powder with a white or off-white colour

Identification

 

A.

Slightly soluble in water. Solubility approximately 0,01 g/100 ml water (20 oC). Sparingly soluble in ethanol. Slightly soluble in diethyl ether. Soluble in acids

 

B.

Specific rotation [α]20 D

+7,0o to +7,4o (0,1 % in a 1N de HCl solution)

C.

pH of a 5 % slurry

Between 6,0 and 9,0

Purity

 

Sulphates (as H2SO4)

Not more than 1 g/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 355 ADIPIC ACID

Definition

 

Chemical name

Hexanedioic acid, 1,4-butanedicarboxylic acid

Einecs