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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)
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)
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No longer in force, Date of end of validity: 30/11/2012; Repealed by 32012R0231
. Latest consolidated version: 10/11/2010
|
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.
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 |
|
||
|
Between 133 oC and 135 oC, after vacuum drying for four hours in a sulphuric acid desiccator |
||
|
An isopropanol solution (1 in 4 000 000) shows absorbance maximum at 254 ± 2 nm |
||
|
|
||
|
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 |
|
||
|
|
||
|
|
||
|
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 |
|
||
|
|
||
|
|
||
|
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 |
|
||
|
121,5 oC to 123,5 oC |
||
|
|
||
|
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 |
|
||
|
Freely soluble in water, sparingly soluble in ethanol |
||
|
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 |
||
|
|
||
|
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 |
|
||
|
|
||
|
|
||
|
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 |
|
|||
|
|
|||
|
|
|||
|
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 |
|
||
|
115 oC to 118 oC |
||
|
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 |
||
|
|
||
|
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 |
|
||
|
115 oC to 118 oC, after vacuum drying in a sulphuric acid desiccator |
||
|
Melting range of p-hydroxybenzoic acid derived from the sample is 213 oC to 217 oC |
||
|
|
||
|
|
||
|
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 |
|
||
|
125 oC to 128 oC |
||
|
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 |
|
||
|
|
||
|
|
||
|
|
||
|
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 |
|
||
|
|
||
|
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 |
|
|||
|
|
|||
|
|
|||
|
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 |
|
||
|
|
||
|
|
||
|
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 |
|
||
|
|
||
|
|
||
|
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 |
|
||
|
|
||
|
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 |
|
||
|
|
||
|
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 |
|
||
|
|
||
|
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 |
|
||
|
|
||
|
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 |
|
||
|
68,5 oC to 70,5 oC |
||
|
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 |
|
||
|
56 oC to 58 oC |
||
|
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 |
|
||
|
|
||
|
|
||
|
|
||
|
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 |
|
||
|
296 oC to 303 oC |
||
|
Absorption maxima in 0,1 N HCl (0,0005 % w/v) at 302 nm, 258 nm and 243 nm |
||
|
|
|||
|
|
|||
|
|
|||
|
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 |
|
||||||
|
On adding a few crystals of natamycin on a spot plate, to a drop of:
which changes into pale red after a few minutes |
||||||
|
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 |
||||||
|
5,5 to 7,5 (1 % w/v solution in previously neutralised mixture of 20 parts dimethylformamide and 80 parts of water) |
||||||
|
[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 |
|
||
|
|
||
|
|
||
|
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 |
|
||
|
After dilution positive tests for CO2 and methanol |
||
|
17 oC |
||
|
Boiling point |
172 oC with decomposition |
||
|
Approximately 1,25 g/cm3 |
||
|
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 |
|
||
|
|
||
|
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 |
|
||
|
|
||
|
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 |
|
||
|
|
||
|
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 |
|
||
|
|
||
|
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 |
|
||
|
|
||
|
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 |
|
||
|
118 oC at 760 mm pressure (of mercury) |
||
|
About 1,049 |
||
|
|
||
|
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 |
|
||
|
Not less than 7,5 and not more than 9,0 |
||
|
|
||
|
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 |
|
|||
|
Not less than 8,0 and not more than 9,5 |
|||
|
|
|||
|
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 |
|
||
|
Not less than 4,5 and not more than 5,0 |
||
|
|
||
|
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 |
|
|||
|
Not less than 6,0 and not more than 9,0 |
|||
|
|
|||
|
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 |
|
||
|
|
||
|
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 |
|
||
|
- 22 oC |
||
|
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 |
|
||
|
|
||
|
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 |
|
||
|
|
||
|
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 |
|
||
|
|
||
|
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 |
|
||
|
At approximately 171 oC |
||
|
|
||
|
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 |
|
||
|
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 |
|
||
|
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 |
|
||
|
|
||
|
|
||
|
|
||
|
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 |
|
||
|
286 oC-302 oC (closed capillary, rapid heating) |
||
|
|
||
|
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 |
|
||
|
Between 189 oC and 193 oC with decomposition |
||
|
|
||
|
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 |
|
||
|
|
||
|
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 |
|
||
|
|
||
|
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 |
|
||
|
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 |
|
||
|
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 |
|
||
|
|
||
|
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 |
|
||
|
Insoluble in water, freely soluble in ethanol, miscible in ether |
||
|
In absolute ethanol the maximum absorption is about 292 nm |
||
|
Purity |
|
||
|
Refractive index |
n D 201,503-1,507 |
||
| Specific absorption
|
(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 |
(292 nm) 72-76E 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 |
|
||
|
Maximum absorptions in absolute ethanol at about 298 nm and 257 nm |
||
|
Purity |
|
||
| Specific absorption
|
|
||
|
|
|||
|
Refractive index |
|
||
|
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 |
|
||
|
Maximum absorptions in absolute ethanol at about 298 nm and 257 nm |
||
|
Purity |
|
||
| Specific absorption
|
|
||
|
|
|||
|
Refractive index |
|
||
|
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 |
|
||
|
Slightly soluble in water, freely soluble in ethanol, ether and propane-1,2-diol |
||
|
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
|
|
||
|
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 |
|
||
|
Insoluble in water, freely soluble in ethanol, ether and propane-1,2-diol |
||
|
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
|
|
||
|
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 |
|
||
|
Insoluble in water, freely soluble in ethanol and ether |
||
|
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
|
|
||
|
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 |
|
||
|
About 164 oC to 172 oC with decomposition |
||
|
|
||
|
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 |
|
||
|
Freely soluble in water, very slightly soluble in ethanol |
||
|
|
||
|
|
||
|
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 |
|
||
|
Practically insoluble in water; soluble in ethanol |
||
|
Not less than 126,5 oC |
||
|
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 |
|
||
|
Insoluble in water, freely soluble in ethanol |
||
|
Between 48 °C and 63 °C |
||
|
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
|
|
||
| Specific absorption
|
|
||
|
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 |
|
||
|
Insoluble in water and propane- 1,2-diol |
||
|
Freely soluble in ethanol |
|||
|
At 70 oC |
||
|
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
|
|
||
|
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 |
|
||
|
|||
|
Description |
|
||
|
|||
|
Identification |
|
||
|
|
||
|
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 |
|
||
|
|||
|
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 |
|
||
|
|
||
|
|
||
|
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 |
|
||
|
Ignite potassium lactate solution to an ash. The ash is alkaline, and an effervescence occurs when acid is added |
||
|
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 |
||
|
|
||
|
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 |
|
||
|
|
||
|
Soluble in water and practically insoluble in ethanol |
||
|
Purity |
|
||
|
Loss on drying |
Determined by drying at 120 oC for four hours: |
||
|
|||
|
|||
|
|||
|
|||
|
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 |
|
||
|
|||
|
Molecular weight |
|
||
|
|||
|
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 |
|
||
|
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 |
|
||
|
|||
|
Molecular weight |
|
||
|
|||
|
Assay |
Content not less than 99 % on the anhydrous basis |
||
|
Description |
Crystalline white powder or colourless crystals |
||
|
Identification |
|
||
|
|
||
|
Purity |
|
||
|
Loss on drying |
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 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 |
|
||
|
|
||
|
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 |
|
|||
|
|
|||
|
Purity |
|
|||
|
Loss on drying |
Determined by drying at 180 oC for four hours: |
|||
|
not more than 1,0 % |
|||
|
not more than 13,5 % |
|||
|
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 |
|
||
|
|
||
|
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 |
|
||
|
|
||
|
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 |
|
||
|
|
||
|
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 |
|
||
|
|
||
|
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 |
|
||
|
|
||
|
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 |
|
||
|
Between 168 oC and 170 oC |
||
|
|
||
|
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 |
|
||
|
|
||
|
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 |
|
||
|
|
||
|
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 |
|
||
|
|
||
|
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 |
|
||
|
|
||
|
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 |
|
||
|
|
||
|
1 gram is soluble in 1 ml of water, insoluble in ethanol |
||
|
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 |
|
||
|
|
||
|
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 |
|
||
|
|
||
|
Freely soluble in water. Insoluble in ethanol or ether |
||
|
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 |
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Identification |
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|
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Freely soluble in water. Insoluble in ethanol |
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Between 8,4 and 9,6 |
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Purity |
|
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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 % |
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Water-insoluble substances |
Not more than 0,2 % on the anhydrous basis |
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Fluoride |
Not more than 10 mg/kg (expressed as fluorine) |
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Arsenic |
Not more than 3 mg/kg |
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Cadmium |
Not more than 1 mg/kg |
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Lead |
Not more than 4 mg/kg |
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Mercury |
Not more than 1 mg/kg |
E 339 (iii) TRISODIUM PHOSPHATE
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Synonyms |
Sodium phosphate |
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Tribasic sodium phosphate |
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Trisodium orthophosphate |
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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 |
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Chemical name |
Trisodium monophosphate |
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Trisodium phosphate |
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Trisodium orthophosphate |
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Einecs |
231-509-8 |
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Chemical formula |
Anhydrous: Na3PO4 |
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Hydrated: Na3PO4 · nH2O (n = 1/2, 1, 6, 8, or 12) |
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Molecular weight |
163,94 (anhydrous) |
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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 |
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P2O5 content |
Between 40,5 % and 43,5 % on the anhydrous basis |
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Description |
White odourless crystals, granules or crystalline powder |
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Identification |
|
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|
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Freely soluble in water. Insoluble in ethanol |
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Between 11,5 and 12,5 |
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Purity |
|
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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 % |
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Water insoluble substances |
Not more than 0,2 % on the anhydrous basis |
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Fluoride |
Not more than 10 mg/kg (expressed as fluorine) |
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Arsenic |
Not more than 3 mg/kg |
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Cadmium |
Not more than 1 mg/kg |
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Lead |
Not more than 4 mg/kg |
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Mercury |
Not more than 1 mg/kg |
E 340 (i) MONOPOTASSIUM PHOSPHATE
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Synonyms |
Monobasic potassium phosphate |
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Monopotassium monophosphate |
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Potassium orthophosphate |
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Definition |
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Chemical name |
Potassium dihydrogen phosphate |
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Monopotassium dihydrogen orthophosphate |
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Monopotassium dihydrogen monophosphate |
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Einecs |
231-913-4 |
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Chemical formula |
KH2PO4 |
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Molecular weight |
136,09 |
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Assay |
Content not less than 98,0 % after drying at 105 oC for four hours |
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P2O5 content |
Between 51,0 % and 53,0 % on the anhydrous basis |
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Description |
Odourless, colourless crystals or white granular or crystalline powder, hygroscopic |
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Identification |
|
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|
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Freely soluble in water. Insoluble in ethanol |
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Between 4,2 and 4,8 |
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Purity |
|
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Loss on drying |
Not more than 2,0 % determined by drying at 105 oC for four hours |
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Water-insoluble substances |
Not more than 0,2 % on the anhydrous basis |
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Fluoride |
Not more than 10 mg/kg (expressed as fluorine) |
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Arsenic |
Not more than 3 mg/kg |
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Cadmium |
Not more than 1 mg/kg |
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Lead |
Not more than 4 mg/kg |
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Mercury |
Not more than 1 mg/kg |
E 340 (ii) DIPOTASSIUM PHOSPHATE
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Synonyms |
Dipotassium monophosphate |
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Secondary potassium phosphate |
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Dipotassium acid phosphate |
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Dipotassium orthophosphate |
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Dibasic potassium phosphate |
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Definition |
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Chemical name |
Dipotassium hydrogen monophosphate |
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Dipotassium hydrogen phosphate |
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Dipotassium hydrogen orthophosphate |
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Einecs |
231-834-5 |
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Chemical formula |
K2HPO4 |
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Molecular weight |
174,18 |
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Assay |
Content not less than 98 % after drying at 105 oC for four hours |
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P2O5 content |
Between 40,3 % and 41,5 % on the anhydrous basis |
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Description |
Colourless or white granular powder, crystals or masses; deliquescent substance |
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Identification |
|
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|
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Freely soluble in water. Insoluble in ethanol |
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Between 8,7 and 9,4 |
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Purity |
|
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Loss on drying |
Not more than 2,0 % determined by drying at 105 oC for four hours |
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Water-insoluble substances |
Not more than 0,2 % on the anhydrous basis |
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Fluoride |
Not more than 10 mg/kg (expressed as fluorine) |
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Arsenic |
Not more than 3 mg/kg |
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Cadmium |
Not more than 1 mg/kg |
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Lead |
Not more than 4 mg/kg |
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Mercury |
Not more than 1 mg/kg |
E 340 (iii) TRIPOTASSIUM PHOSPHATE
|
Synonyms |
Potassium phosphate |
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Tribasic potassium phosphate |
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Tripotassium orthophosphate |
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Definition |
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Chemical name |
Tripotassium monophosphate |
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Tripotassium phosphate |
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Tripotassium orthophosphate |
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Einecs |
231-907-1 |
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Chemical formula |
Anhydrous: K3PO4 |
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Hydrated: K3PO4 · nH2O (n = 1 or 3) |
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Molecular weight |
212,27 (anhydrous) |
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Assay |
Content not less than 97 % calculated on the ignited basis |
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P2O5 content |
Between 30,5 % and 33,0 % on the ignited basis |
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Description |
Colourless or white, odourless hygroscopic crystals or granules. Hydrated forms available include the monohydrate and trihydrate |
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Identification |
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|
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Freely soluble in water. Insoluble in ethanol |
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Between 11,5 and 12,3 |
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Purity |
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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 |
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Water insoluble substances |
Not more than 0,2 % on the anhydrous basis |
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Fluoride |
Not more than 10 mg/kg (expressed as fluorine) |
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Arsenic |
Not more than 3 mg/kg |
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Cadmium |
Not more than 1 mg/kg |
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Lead |
Not more than 4 mg/kg |
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Mercury |
Not more than 1 mg/kg |
E 341 (i) MONOCALCIUM PHOSPHATE
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Synonyms |
Monobasic calcium phosphate |
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Monocalcium orthophosphate |
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Definition |
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Chemical name |
Calcium dihydrogen phosphate |
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Einecs |
231-837-1 |
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Chemical formula |
Anhydrous: Ca(H2PO4)2 |
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Monohydrate: Ca(H2PO4)2 · H2O |
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Molecular weight |
234,05 (anhydrous) |
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252,08 (monohydrate) |
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Assay |
Content not less than 95 % on the dried basis |
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P2O5 content |
Between 55,5 % and 61,1 % on the anhydrous basis |
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Description |
Granular powder or white, deliquescent crystals or granules |
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Identification |
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Between 23,0 % and 27,5 % (anhydrous) |
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Between 19,0 % and 24,8 % (monohydrate) |
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Purity |
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Loss on drying |
Not more than 14 % determined by drying at 105 oC for four hours (anhydrous) |
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Not more than 17,5 % determined by drying at 60 oC for one hour, then at 105 oC for four hours (monohydrate) |
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Loss on ignition |
Not more than 17,5 % after ignition at 800 oC ± 25 oC for 30 minutes (anhydrous) |
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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) |
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Fluoride |
Not more than 30 mg/kg (expressed as fluorine) |
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Arsenic |
Not more than 3 mg/kg |
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Cadmium |
Not more than 1 mg/kg |
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Lead |
Not more than 4 mg/kg |
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Mercury |
Not more than 1 mg/kg |
E 341 (ii) DICALCIUM PHOSPHATE
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Synonyms |
Dibasic calcium phosphate |
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Dicalcium orthophosphate |
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Definition |
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Chemical name |
Calcium monohydrogen phosphate |
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Calcium hydrogen orthophosphate |
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Secondary calcium phosphate |
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Einecs |
231-826-1 |
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Chemical formula |
Anhydrous: CaHPO4 |
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Dihydrate: CaHPO4 · 2H2O |
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Molecular weight |
136,06 (anhydrous) |
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172,09 (dihydrate) |
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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 |
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P2O5 content |
Between 50,0 % and 52,5 % on the anhydrous basis |
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Description |
White crystals or granules, granular powder or powder |
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Identification |
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Sparingly soluble in water. Insoluble in ethanol |
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Purity |
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Loss on ignition |
Not more than 8,5 % (anhydrous), or 26,5 % (dihydrate) after ignition at 800 oC ± 25 oC for 30 minutes |
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Fluoride |
Not more than 50 mg/kg (expressed as fluorine) |
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Arsenic |
Not more than 3 mg/kg |
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Cadmium |
Not more than 1 mg/kg |
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Lead |
Not more than 4 mg/kg |
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Mercury |
Not more than 1 mg/kg |
E 341 (iii) TRICALCIUM PHOSPHATE
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Synonyms |
Calcium phosphate, tribasic |
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Calcium orthophosphate |
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Pentacalcium hydroxy monophosphate |
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Calcium hydroxyapatite |
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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 |
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Chemical name |
Pentacalcium hydroxy monophosphate |
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Tricalcium monophosphate |
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Einecs |
235-330-6 (Pentacalcium hydroxy monophosphate) |
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231-840-8 (Calcium orthophosphate) |
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Chemical formula |
Ca5(PO4)3· OH or Ca3(PO4)2 |
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Molecular weight |
502 or 310 |
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Assay |
Content not less than 90 % calculated on the ignited basis |
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P2O5 content |
Between 38,5 % and 48,0 % on the anhydrous basis |
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Description |
A white, odourless powder which is stable in air |
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Identification |
|
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|
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Practically insoluble in water; insoluble in ethanol soluble in dilute hydrochloric and nitric acid |
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Purity |
|
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Loss on ignition |
Not more than 8 % after ignition at 800 oC ± 25 oC, to constant weight |
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Fluoride |
Not more than 50 mg/kg (expressed as fluorine) |
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Arsenic |
Not more than 3 mg/kg |
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Cadmium |
Not more than 1 mg/kg |
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Lead |
Not more than 4 mg/kg |
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Mercury |
Not more than 1 mg/kg |
E 343(i) MONOMAGNESIUM PHOSPHATE
|
Synonyms |
Magnesiumdihydrogenphosphate |
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|
Magnesiumphosphate, monobasic |
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|
Monomagnesium orthophosphate |
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Definition |
|
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Chemical name |
Monomagnesiumdihydrogenmonophosphate |
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|
Einecs |
236-004-6 |
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Chemical formula |
Mg(H2PO4)2 · nH2O (where n = 0 to 4) |
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Molecular weight |
218,30 (anhydrous) |
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Assay |
Not less than 51,0 % after ignition |
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Description |
White, odourless, crystalline powder, slightly soluble in water |
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Identification |
|
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|
|
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|
Not less than 21,5 % after ignition |
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Purity |
|
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|
Fluoride |
Not more than 10 mg/kg (as fluorine) |
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Arsenic |
Not more than 3 mg/kg |
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Lead |
Not more than 4 mg/kg |
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Cadmium |
Not more than 1 mg/kg |
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Mercury |
Not more than 1 mg/kg |
E 343(ii) DIMAGNESIUM PHOSPHATE
|
Synonyms |
Magnesiumhydrogenphosphate |
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|
Magnesiumphosphate, dibasic |
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|
Dimagnesium orthophosphate |
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|
Secondary magnesiumphosphate |
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Definition |
|
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|
Chemical name |
Dimagnesiummonohydrogenmonophosphate |
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|
Einecs |
231-823-5 |
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|
Chemical formula |
MgHPO4 · nH2O (where n = 0-3) |
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Molecular weight |
120,30 (anhydrous) |
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|
Assay |
Not less than 96 % after ignition |
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|
Description |
White, odourless, crystalline powder, slightly soluble in water |
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|
Identification |
|
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|
|
||
|
Not less than 33,0 % calculated on an anhydrous basis |
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Purity |
|
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|
Fluoride |
Not more than 10 mg/kg (as fluorine) |
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|
Arsenic |
Not more than 3 mg/kg |
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Lead |
Not more than 4 mg/kg |
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Cadmium |
Not more than 1 mg/kg |
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Mercury |
Not more than 1 mg/kg |
E 350 (i) SODIUM MALATE
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Synonyms |
Sodium salt of malic acid |
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Definition |
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Chemical name |
Disodium DL-malate, disodium salt of hydroxybutanedioic acid |
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|
Chemical formula |
Hemihydrate: C4H4Na2O5 · 1/2 H2O |
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Trihydrate: C4H4Na2O5 · 3H2O |
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Molecular weight |
Hemihydrate: 187,05 |
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|
Trihydrate: 232,10 |
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Assay |
Content not less than 98,0 % on the anhydrous basis |
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Description |
White crystalline powder or lumps |
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Identification |
|
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|
|
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|
Positive |
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|
Freely soluble in water |
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Purity |
|
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|
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 |
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|
Alkalinity |
Not more than 0,2 % as Na2CO3 |
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|
Fumaric acid |
Not more than 1,0 % |
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|
Maleic acid |
Not more than 0,05 % |
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|
Arsenic |
Not more than 3 mg/kg |
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|
Lead |
Not more than 5 mg/kg |
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|
Mercury |
Not more than 1 mg/kg |
E 350 (ii) SODIUM HYDROGEN MALATE
|
Synonyms |
Monosodium salt of DL-malic acid |
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Definition |
|
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Chemical name |
Monosodium DL-malate, monosodium 2-DL-hydroxy succinate |
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|
Chemical formula |
C4H5NaO5 |
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|
Molecular weight |
156,07 |
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|
Assay |
Content not less than 99,0 % on the anhydrous basis |
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Description |
White powder |
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|
Identification |
|
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|
|
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|
Positive |
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|
Purity |
|
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|
Loss on drying |
Not more than 2,0 % (110 oC, 3h) |
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|
Maleic acid |
Not more than 0,05 % |
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|
Fumaric acid |
Not more than 1,0 % |
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|
Arsenic |
Not more than 3 mg/kg |
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|
Lead |
Not more than 5 mg/kg |
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|
Mercury |
Not more than 1 mg/kg |
E 351 POTASSIUM MALATE
|
Synonyms |
Potassium salt of malic acid |
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|
Definition |
|
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|
Chemical name |
Dipotassium DL-malate, dipotassium salt of hydroxybutanedioic acid |
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|
Chemical formula |
C4H4K2O5 |
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|
Molecular weight |
210,27 |
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|
Assay |
Content not less than 59,5 % |
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|
Description |
Colourless or almost colourless aqueous solution |
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|
Identification |
|
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|
|
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|
Positive |
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|
Purity |
|
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|
Alkalinity |
Not more than 0,2 % as K2CO3 |
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|
Fumaric acid |
Not more than 1,0 % |
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|
Maleic acid |
Not more than 0,05 % |
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|
Arsenic |
Not more than 3 mg/kg |
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|
Lead |
Not more than 5 mg/kg |
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|
Mercury |
Not more than 1 mg/kg |
E 352 (i) CALCIUM MALATE
|
Synonyms |
Calcium salt of malic acid |
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|
Definition |
|
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|
Chemical name |
Calcium DL-malate, calcium-α-hydroxysuccinate, calcium salt of hydroxybutanedioic acid |
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|
Chemical formula |
C4H5CaO5 |
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|
Molecular weight |
172,14 |
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|
Assay |
Content not less than 97,5 % on the anhydrous basis |
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|
Description |
White powder |
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|
Identification |
|
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|
|
||
|
Positive |
||
|
Slightly soluble in water |
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|
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 |
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|
Definition |
|
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|
Chemical name |
Monocalcium DL-malate, monocalcium 2-DL-hydroxysuccinate |
||
|
Chemical formula |
(C4H5O5)2Ca |
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|
Assay |
Content not less than 97,5 % on the anhydrous basis |
||
|
Description |
White powder |
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|
Identification |
|
||
|
|
||
|
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 |