OpenLegislation

Schedule 5 Purity Criteria

Northern Ireland Not yet in force

Changes not yet applied. Later legislation changes this provision in ways not yet written into the text below:

Each miscellaneous additive for which specific purity criteria are specified or referred to below shall not contain—

(a)

more than 3 milligrams per kilogram of arsenic;

(b)

more than 10 milligrams per kilogram of lead;

(c)

more than 50 milligrams per kilogram of copper, or 25 milligrams per kilogram of zinc or 50 milligrams per kilogram of any combination of copper and zinc;

except in so far as those specific purity criteria provide otherwise or in the case of E 957 Thaumatin.

DescriptionFine white microcrystalline or amorphous powder
ContentNot less than 97 per centum of CaCO3 on a volatile matter-free basis
Volatile matterNot more than 1 per centum (determined by drying at 105°C to constant weight)
Matter insoluble in hydrochloric acidShall comply with the requirement for aluminium, iron, phosphate and matter insoluble in hydrochloric acid in the monograph for chalk in the British Pharmacopoeia 1973 at page 93
ArsenicNot more than 5 mg per kg.
LeadNot more than 20 mg per kg.
Other inorganic impuritiesNot more than 100 mg per kg of any of the following substances, namely antimony, copper, chromium, zinc or barium sulphate, or more than 200 mg per kg of any combination of those substances.
Synonyms

Ethyl 4-hydroxybenzoate

Ethyl ester of p-hydroxybenzoic acid
Synonyms

Ethyl 4-hydroxybenzoate, sodium salt

Sodium ethyl para-hydroxybenzoate
Synonyms

Propyl 4-hydroxybenzoate

Propyl para-hydroxybenzoate n-propyl p-hydroxybenzoate
Synonyms

Propyl 4-hydroxybenzoate, sodium salt

Sodium propyl para-hydroxybenzoate

Sodium n-propyl p-hydroxybenzoate
Synonyms

Methyl 4-hydroxybenzoate

Methyl para-hydroxybenzoate
Synonyms

Methyl 4-hydroxybenzoate, sodium salt

Sodium methyl para-hydroxybenzoate
Synonym

Acid sodium sulphite
The appropriate specific purity criteria contained in Council Directive 65/66/EEC as amended by Council Directive 67/428/EEC.
Synonyms

Potassium bisulhite

Potassium acid sulphite

The appropriate specific purity criteria contained in Council Directive 65/66/EEC as amended by Council Directive 86/604/EECf1.
Synonym

2-Hydroxybiphenyl
Synonyms

Sodium biphenyl-2-yl-oxide

Sodium orthophenylphenate
Synonyms

2-(Thiazol-4-yl) benzimidazole

2-(4-thiazolyl) benzimidazole

The appropriate specific purity criteria contained in Council Directive 65/66/EEC as amended by Council Directive 76/463/EEC.
The criteria in the monograph for nisin contained in the Nutrition Meetings Report Series No. 45A (1969) of the United Nations' Food and Agriculture Organisation at page 53.
SynonymHexamine
SynonymSodium hydrogen diacetate
The specific purity criteria for lactic acid contained in Council Directive 65/66/EEC.
The appropriate specific purity criteria contained in Council Directive 65/66/EEC as amended by Council Directive 76/463/EEC.
The specific purity criteria for carbon dioxide contained in Council Directive 65/66/EEC. Solid or liquid carbon dioxide shall be of equivalent purity to the gas.

DL-Malic acid

The criteria in the monograph for malic acid contained in the Food Chemicals Codex 1972 at page 484 as amended by the Second Supplement to that Codex at page 27, except that the melting range shall be 130°C to 132°C (corrected) and that the method for determining the melting range shall be that specified or a method of equivalent accuracy.

L-Malic Acid

DescriptionWhite or nearly white crystalline powder or granules
Content Melting rangeNot less than 99 per centum of C4H6O5. 99°C to 101°C.
Specific rotation [α] 20°C DNot less than –2.4° and not more than –2.2° using a solution containing 8.5g L-malic and in 100 ml water.

Malic acid

Fumaric acid

Residue on ignition

Water insoluble matter

Shall comply with the limits given in the }monograph for malic acid in the Food Chemicals Codex 1972 at page 484.
The criteria in the monograph for fumaric acid contained in the Food Chemicals Codex 1972 at page 331.
SynonymSodium dihydrogen citrate
SynonymPotassium dihydrogen citrate
SynonymPotassium sodium tartrate
SynonymOrthophosphoric acid
SynonymMonosodium orthophosphate
SynonymDisodium orthophosphate Disodium hydrogen orthophosphate
SynonymTrisodium orthophosphate
SynonymsMonodipotassium orthophosphate Potassium dihydrogen orthophosphate
SynonymsDipotassium orthophosphate Dipotassium hydrogen orthophosphate
SynonymTripotassium orthophosphate
DescriptionColourless or almost colourless aqueous solution. Sodium malate may be derived from either DL-malic acid or L-malic acid.
ContentNot less than 59.5 per centum of C4H4O5Na2.
Maleic acidNot more than 0.05 per centum calculated on the C4H4O5Na2 content.
DescriptionWhite odourless powder. Sodium hydrogen malate may be derived from either DL-malic acid or L-malic acid.
ContentNot less than 99 per centum of C4H5O5Na on a volatile matter-free basis.
Volatile matterNot more than 2 per centum (determined by drying at 110°C for 3 hours)
Maleic acidNot more than 0.05 per centum.
DescriptionColourless or almost colourless aqueous solution. Potassium malate may be derived from either DL-malic acid or L-malic acid.
ContentNot less than 59.5 per centum of C4H4O5K2
Maleic acidNot more than 0.05 per centum calculated on the C4H4O5K2 content.
DescriptionWhite odourless powder. Calcium malate may be derived from either DL-malic acid or L-malic acid
ContentNot less than 97.5 per centum of C4H4O5Ca on a volatile matter-free basis.
Volatile matterNot more than 2 per centum (determined by drying at 110°C for 3 hours)
Maleic acidNot more than 0.05 per centum.
FluorideNot more than 30 mg per kg on a volatile matter-free basis
DescriptionWhite odourless powder. Calcium hydrogen malate may be derived from either DL-malic acid or L-malic acid
ContentNot less than 97.5 per centum of (C4H5O5)2Ca on a volatile matter-free basis.
Volatile matterNot more than 2 per centum (determined by drying at 110°C for 3 hours)
Maleic acidNot more than 0.05 per centum.
FluorideNot more than 30 mg per kg on a volatile matter-free basis
DescriptionWhite or yellow powder which consists chiefly of a mixture of polyesters obtained by the controlled dehydration of L-(+)-tartaric acid together with unchanged L-(+)-tartaric acid.
Specific absorption 1 per centum E 1 cmNot more than 1.5 × 10−2at 430 nm. (determined using a filtered aqueous solution).
IdentificationPlace 5 to 10 mg of sample in a test tube. Add 2 ml sulphuric acid (about 94 per centum H2SO4) plus two drops of resorcinol reagent (2 g. resorcinol dissolved in 100 ml water plus 0.5 ml sulphuric acid) and heat to 150°C. An intense violet colour is produced.
Content

Not less than the equivalent of 105 per centum of tartaric acid (C4H6O6). The esterified tartaric acid content shall be not less than 27 per centum and not more than 38 per centum of the tartaric acid equivalent when determined by the following method:

Add three drops of bromothymol blue indicator (0.04 per centum weight/volume solution of bromothymol blue in 95 per centum volume/volume ethanol) to 50 ml of freshly prepared 2 per centum weight/volume cold aqueous solution of metatartaric acid. Titrate with N aqueous sodium hydroxide solution to a blue-green colour (T1ml.). Add a further 20 ml of N aqueous sodium hydroxide solution and leave for 2 hours at room temperature.

Titrate with N aqueous sulphuric acid solution (T2ml).

Calculations:

Tartaric acid equivalent=7.5(T1+20-T2)per centum Esterfied tartaric acid=100(20-T2)T1=20-T2per centum
Specific rotation [α] 20°C DNot less than + 12.5° and not more than + 13.5° (using a filtered 10 per centum weight/volume aqueous solution).
Matter insoluble in water (at about 20°C)Not more than 2.5 per centum (insoluble matter weighed after drying for 3 hours at 70°C in a vacuum oven).
Pyruvic acidNot more than 0.5 per centum.
The criteria in the monograph for adipic acid contained in the Food Chemicals Codex 1972 at page 21.
The criteria in the monograph for succinic acid contained in the Food Chemicals Codex 1972 at page 800.
SynonymAmmonium citrate
The criteria in the monograph for ammonium citrate contained in the British Pharmaceutical Codex 1973 at page 830.
SynonymSodium calciumedate
The criteria in the monograph for sodium calciumedetate contained in the British Pharmacopoeia 1973 at page 425.
SynonymPropylene glycol alginate
The specific purity criteria for agar contained in Council Directive 78/663/EEC.
The specific purity criteria for carrageenan contained in Council Directive 78/663/EEC, as amended by Article 1 of Commission Directive 90/612/EECf2.
SynonymCarob gum
SynonymGum arabic
The specific purity criteria for xanthan gum contained in Council Directive 78/663/EEC, as amended by Article 1.2(b) of Council Directive 82/504/EEC.
SynonymSterculia gum
The criteria in the monograph for karaya gum contained in the Food Chemicals Codex 1981 at page 157.
As set out in the Annex to Council Directive 78/663/EEC.
SynonymPolysorbate 20
The criteria in the monograph for polysorbate 20 contained in the Food Chemicals Codex 1981 at page 234.
SynonymPolysorbate 80
The criteria in the monograph for polysorbate 80 contained in the Food Chemicals Codex 1981 at page 236 except that the final sentence of the description (requirement to conform to the regulations of the federal Food and Drug Administration pertaining to specifications for fats or fatty acids derived from edible sources) shall be deleted.
SynonymPolysorbate 40
The criteria in the monograph for polyoxyethylene (20) sorbitan monopalmitate contained in the Food and Nutrition Paper No. 4 (1978) of the United Nations' Food and Agriculture Organisation at page 278.
SynonymPolysorbate 60
The criteria in the monograph for polysorbate 60 contained in the Food Chemicals Codex 1981 at page 235 except that the final sentence of the description (requirement to conform to the regulations of the federal Food and Drug Administration pertaining to specifications for fats or fatty acids derived from edible sources) shall be deleted.
SynonymPolysorbate 65
The criteria in the monograph for polysorbate 65 contained in the Food Chemicals Codex 1981 at page 235 except that the final sentence of the description (requirement to conform to the regulations of the federal Food and Drug Administration pertaining to specifications for fats or fatty acids derived from edible sources) shall be deleted.
DescriptionAmmonium phosphatides exist as an unctuous semi-solid (at 25°C). They consist essentially of a mixture of the ammonium salts of phosphatidic acids derived from partially hardened rapeseed oil together with unreacted partially hardened rape-seed oil.
Matter insoluble in petroleum ether (40°C-60°C)Total: Not more than 2.5 per centum. Inorganic matter: not more than 0.2 per centum.
pH of an aqueous extract of melted ammonium phosphatidesNot less than 6.0 and not more than 8.0
PhosphorusNot less than 3.0 per centum and not more than 3.4 per centum.
Ammonium nitrogenNot less than 1.2 per centum and not more than 1.5 per centum.
ArsenicNot more than 5 mg per kg.
SynonymsDicalcium pyrophosphate Calcium pyrophosphate
The criteria in the monograph for calcium pyrophosphate contained in the Food Chemicals Codex 1972 at page 153.
Description

Calcium polyphosphates exist as a fine white powder or crystals or colourless glassy platelets. They are reproducible heterogeneous mixtures of calcium salts of condensed polyphosphoric acids of general formula:

H(n+2)PnO(3n+1)

where

  • n shall be not less than 2

Content (expressed as P2O5)Not less than 50 per centum and not more 71 per centum of an anhydrous basis.
pH (1 per centum aqueous solution)For water soluble phosphates only: not less than 4.0 and not more than 9.0.
Cyclic phosphateNot more than 8 per centum calculated on the P2O5 content.
FluorideNot more than 15 mg per kg calculated on the P2O5 content.
The specific purity criteria for microcrystalline cellulose contained in Council Directive 78/663/EEC, as amended by Article 1.2(c) of Council Directive 82/504/EEC.
SynonymAlpha-cellulose
The criteria in the monograph for cellulose, powdered, contained in the Food Chemicals Codex 1981 at page 80. Additionally the level of lead present shall not exceed 1 mg per kg.
SynonymMethylethylcellulose
SynonymSodium carboyxmethylcellulose
The specific purity criteria for carboxymethylcellulose contained in Council Directive 78/663/EEC, as amended by Article 1 of Commission Directive 90/612/EEC.
SynonymAcetylated mono- and diglycerides
SynonymCitroglycerides
SynonymMono- and diacetyl tartaric acid esters of mono-and diglycerides
The specific purity criteria for sucrose esters of fatty acids contained in Council Directive 78/663/EEC, as amended by Article 1 of Commission Directive 90/612/EEC and Article 1 of Commission Directive 92/4/EECf3.
The specific purity criteria for sucroglycerides contained in Council Directive 78/663/EEC, as amended by Article 1.2(e) of Council Directive 82/504/EEC.
The specific purity criteria for polyglycerol esters of non-polymerised fatty acids contained in Council Directive 78/663/EEC.
Synonym of castor oil.Polyglycerol esters of polycondensed fatty acids
DescriptionThe polyglycerol esters of polycondensed fatty acids of castor oil exist as a highly viscous liquid (at 25°C). They are essentially a complex mixture of the partial esters and ethers of polyglycerol with linearly interesterified (polycondensed) fatty acids derived from castor oil. The polycondensed castor oil fatty acids are prepared by condensation in the absence of oxygen and have an average of about 5 fatty acid residues per molecule. The polyglycerol moiety is predominantly di-, tri- and tetra-glycerol and contains not more than 10 per centum of polyglycerols equal to or higher than heptaglycerol.
Refractive index, m65D°CNot less than 1.4630 and not more than 1.4665.
Hydroxyl valueNot less than 80 and not more than 100.
Iodine valueNot less than 72 and not more than 103 (Wijs).
Acid valueNot more than 6 mg KOH per g.
SynonymPropylene glycol esters of fatty acids.
The specific purity criteria for propane-1,2-diol esters of fatty acids contained in Council Directive 78/663/EEC, as amended by Article 1.2(f) of Council Directive 82/504/EEC.
The criteria in the monograph for sorbitan monostearate contained in the Food Chemicals Codex 1981 at page 307 except that the final sentence of the description (requirement to conform to the regulations of the federal Food and Drug Administration pertaining to specifications for fats or fatty acids derived from edible sources) shall be deleted.
The criteria in the monograph for sorbitan tristearate contained in the Food and Nutrition Paper No. 4 (1978) of the United Nations' Food and Agriculture Organisation at page 297.
The criteria in the monograph for sorbitan monolaurate contained in the British Pharmaceutical Codex 1973 at page 465.
The criteria in the monograph for sorbitan monooleate contained in the British Pharmaceutical Codex 1973 at page 466.
The criteria in the monograph for sorbitan monopalmitate contained in the Food and Nutrition Paper No. 4 (1978) of the United Nations' Food and Agriculture Organisation at page 293.
DescriptionColourless crystals or white granular or crystalline powder. The anhydrous salt is hygroscopic and the decahydrate is efflorescent.
ContentNot less than 98 per centum of Na2CO2 on a volatile matter-free basis.
Volatile matter

  • Not more than:

    • 2 per centum for the non-hydrated substance;

    • 15 per centum for the monohydrate;

    • 65 per centum for the decahydrate; (determined by the method for loss on drying in the monograph for sodium carbonate in the Food Chemicals Codex 1972 at page 731.)

Matter insoluble in dilute ammonia solution

  • Not more than 0.12 per centum on a volatile matter-free basis, determined by the following method:

    • Boil 5 g of hydrated sodium carbonate, or 2.5 g of anhydrous sodium carbonate, with 50 ml of water and 10 ml of dilute ammonia solution (about 10 per centum NH3). Filter and wash the residue with water, then ignite to constant weight.

SulphateNot more than 0.4 per centum on a volatile matter-free basis.
ChlorideNot more than 0.4 per centum on a volatile matter-free basis
IronNot more than 40 mg per kg on a volatile matter-free basis.
SynonymSodium bicarbonate
The criteria in the monograph for sodium bicarbonate contained in the Food Chemicals Codex 1972 at page 727.
The criteria in the monograph for sodium sesqicarbonate contained in the Food Chemicals Codex 1972 at page 765.
Description

  • The anhydrous form is a white granular powder.

  • The hydrated form consists of small white translucent crystals or granules.

ContentNot less than 98 per centum K2CO3 on a volatile matter-free basis.
Volatile matter

  • Not more than:

    • 2 per centum for the non-hydrated substance;

    • 18 per centum for the hydrated substance; (determined by drying at 180°C for 4 hours)
SynonymPotassium bicarbonate
The criteria in the monograph for potassium bicarbonate contained in the Food Chemicals Codex 1972 at page 642.
The criteria in the monograph for ammonium carbonate contained in the Food Chemicals Codex 1972 at page 45.
SynonymAmmonium bicarbonate
The criteria in the monograph for ammonium bicarbonate contained in the Food Chemicals Codex 1972 at page 44.
The criteria in the monograph for concentrated hydrochloric acid contained in the European Pharmacopoeia Vol. II, 1971 at page 145.
The criteria in the monograph for potassium chloride contained in the Food Chemicals Codex 1972 at page 646.
The criteria in the monograph for sulphuric acid contained in the Food Chemicals Codex 1972 at page 802.
The criteria in the monograph for sodium sulphate contained in the Food Chemicals Codex 1972 at page 775.
The criteria in the monograph for potassium sulphate contained in the Food Chemicals Codex 1972 at page 670.
The criteria in the monograph for calcium sulphate contained in the Food Chemicals Codex 1972 at page 163.
SynonymsPotassium aluminium sulphate Potash alum.
The criteria in the monograph for alum contained in the European Pharmacopoeia Vol. 1, 1969 at page 243.
The criteria in the monograph for sodium hydroxide contained in the Food Chemicals Codex 1972 at page 743.
The criteria in the monograph for potassium hydroxide contained in the Food Chemicals Codex 1972 at page 652.
DescriptionSoft white powder.
Solubility1 g dissolves in 630 ml of water at 25°C, and in 1300 ml of boiling water. Soluble in glycerol and in a saturated solution of sucrose. Insoluble in ethanol.
ContentNot less than 92 per centum of Ca(OH)2.
Matter insoluble in dilute Hydrochloric acid (about 10 per centum weight/ volume HCL)Not more than 0.5 per centum.
Magnesium and alkali saltsNot more than 6 per centum, determined by the method in the monograph for calcium hydroxide contained in the Food Chemicals Codex 1972 at page 131 except that the weight of the residue shall not exceed 15 mg.
CarbonateWhen 2 g of calcium hydroxide is mixed with 50 ml of water and an excess of dilute hydrochloric acid (approximately 2N) is added, no more than a slight effervescence is produced.
SulphateNot more than 0.35 per centum.
FluorideNot more than 50 mg per kg.
The criteria in the monograph for ammonium hydroxide contained in the Food Chemicals Codex 1972 at page 48.
The criteria in the monograph for magnesium hydroxide contained in the British Pharmaceutical Codex 1973 at page 277.
The criteria in the monograph for calcium hydroxide contained in the Food Chemicals Codex 1972 at page 138.
SynonymsSodium hexacyanoferrate (II)
The criteria in the monograph for sodium ferrocyanide contained in the Food Chemicals Codex 1972 at page 741.
SynonymPotassium hexacyanoferrate (II)
DescriptionOdourless lemon yellow crystals.
SolubilitySoluble in water and in acetone. Insoluble in ethanol, in ether and in hydrocarbons.
ContentNot less than 98 per centum of K4Fe(CN)6. 3H2O.
Free moistureNot more than 1 per centum (determined by the method for free moisture in the monograph for sodium ferrocyanide in the Food Chemicals Codex 1972 at page 741).
ChlorideNot more than 0.1 per centum.
SulphateNot more than 0.1 per centum.
The criteria in the monograph for sodium aluminium phosphate, acidic contained in the Food Chemicals Codex 1972 at page 722.
SynonymSilica, chemically prepared.
DescriptionSilica aerogel is a whie fluffy powdered or granular microcellular silica. Hydrated silica is a precipitated hydrated silicon dioxide occurring as a fine white amorphous powder or as beads or granules.
Content

  • Silica aerogel: not less than 90 per centum of SiO2.

  • Hydrated silica: not less than 91 per centum of SiO2 on a volatile matter-free basis.

Volatile matterHydrated silica: not more than 7 per centum (determined by drying at 105°C for 2 hours).
Loss on ignitionNot more than 13 per centum (determined by ignition at 1000°C to constant weight).
Soluble ionisable salts (expressed as Na2SO4)Not more than 5 per centum.
DescriptionWhite to off-white free-flowing powder.
Solubility

  • Insoluble in water.

  • Forms a gel with mineral acids.

Content:
(expressed as SiO2)Not less than 72 per centum and not more than 78 per centum on a volatile matter-free basis.
(expressed as CaO)Not less than 16 per centum and not more than 21 per centum on a volatile matter-free basis.
(expressed as Na2O)Not less than 2 per centum and not more than 4 per centum on a volatile matter-free basis.
Volatile matterNot more than 6 per centum (determined by drying at 105°C for 2 hours).
Loss on ignitionNot less than 7 per centum and not more than 14 per centum (determined by ignition at 1000°C to constant weight).
The criteria in the monograph for magnesium silicate contained in the Food Chemicals Codex 1972 at page 479.
The criteria in the monograph for magnesium trisilicate contained in the British Pharmacopoeia 1973 at page 276.
DescriptionTalc is a native hydrous magnesium silicate sometimes containing a small proportion of aluminium silicate
It shall comply with the requirements for appearance, characteristics and limits of impurities in the monograph for magnesium silicate contained in the Nutrition Meetings Report Series 46B 1970 of the Food and Agriculture Organisation of the United Nations at page 114. The amount of material soluble in dilute hydrochloric acid shall be not more than 2 per centum and the amount of water soluble substances shall be not more than 0.2 per centum.
Synonyms

  • Aluminium sodum silicate.

  • Sodium aluminosilicate.

  • Sodium silicoaluminate.

DescriptionFine white amorphous powder or beads.
Content:
(expressed as SiO2)Not less than 70 per centum and not more than 80 per centum on a volatile matter-free basis.
(expressed as Al2O3)Not less than 8 per centum and not more than 11 per centum on a volatile matter-free basis.
(expressed as Na2O)Not less than 5 per centum and not more than 10 per centum on a volatile matter-free basis.
Volatile matterNot more than 8 per centum (determined by drying at 105°C for 2 hours)
Loss on ignitionNot less than 10 per centum and not more than 14 per centum (determined by ignition at 1000°C to constant weight).
Synonyms

  • Aluminium calcium silicate.

  • Calcium aluminosilicate.

  • Calcium silicoaluminate.

DescriptionFine white free-flowing powder.
Content:
(expressed as SiO2)Not less than 44 per centum and not more than 50 per centum on a volatile matter-free basis.
(expressed as Al2O3)Not less than 3 per centum and not more than 5 per centum on a volatile matter-free basis.
(expressed as CaO)Not less than 32 per centum and not more than 38 per centum on a volatile matter-free basis.
(expressed as Na2O)Not less than 0.5 per centum and not more than 4 per centum on a volatile matter-free basis.
Volatile matterNot more than 10 per centum (determined by drying at 105°C for 2 hours).
Loss on ignitionNot less than 14 per centum and not more than 18 per centum (determined by ignition at 1000°C to constant weight).
SynonymD-Glucono-l,5-lactone
The criteria in the monograph for glucono delta-lactone contained in the Food Chemicals Codex 1972 at page 346.
The criteria in the monograph for sodium gluconate contained in the Food Chemicals Codex 1972 at page 742.
DescriptionWhite free-flowing powder.
SolubilityFreely soluble in water. Practically insoluble in ethanol and in ether.
ContentNot less than 97 per centum of C6H11O7K on a volatile matter-free basis.
Volatile matterNot more than 3 per centum (determined by drying in a vacuum at 105°C for 4 hours).
Reducing substances (expressed as glucose)Not more than 0.5 per centum.
The criteria in the monograph for calcium gluconate contained in the Food Chemicals Codex 1972 at page 129.
Synonyms

  • Sodium hydrogen L-glutamate.

  • Sodium glutamate.

  • Glutamic acid, sodium salt.

FormulaC5H8NNaO4.H2O (molecular weight 187.13).
The criteria in the monograph for monosodium L-glutamate contained in the Food Chemicals Codex 1981 at page 203.
Synonyms

  • Guanosine 5' -(disodium phosphate)

  • Sodium 5'-guanylate.

  • Disodium guanosine 5'-monophosphate.

FormulaC10H12N5Na2O8P.xH2O (molecular weight (anhydrous) 407.20).
The criteria in the monograph for disodium guanylate contained in the Food Chemicals Codex 1981 at page 105.
Synonyms

  • Inosine 5'-(disodium phosphate)

  • Sodium 5'-inosate.

  • Disodium inosine 5'-monophosphate.

FormulaC10H11N4Na2O8P.xH2O (molecular weight (anhydrous) 392.19).
The criteria in the monograph for disodium inosinate contained in the Food Chemicals Codex 1981 at page 106.
Description

  • White or nearly white crystalline powder consisting of a mixture of guanosine 5' -(disodium phosphate) and inosine 5' -(disodium phosphate) in approximately equal proportions.

  • Soluble in water, practically insoluble in ethanol.

ContentNot less than 97% and not more than 102% of C10H12N5Na2O8P and C10H11N4Na2O8P, and not less than 47% and not more than 53% of C10H12N5Na2O8P or of C10H11N4Na2O8P, in every case calculated on an anhydrous basis.
MoistureNot less than 22% and not more than 26% (Karl Fischer).
pH (5% aqueous solution)Not less than 7.0 and not more than 8.5.
Ammonium salts

  • Place 100 mg of sample in a test tube.

  • Add 50 mg magnesium oxide plus 1 ml of water.

  • Heat on a water bath for 5 minutes; the vapour evolved does not affect the colour of moist litmus paper.

Amino acidsPlace 5 ml of a 0.1% (weight/volume) solution in a test tube. Add 1 ml of a 2% (weight/volume) solution of ninhydrin and heat for 3 minutes; no blue colour is produced.
Other nucleotidesThe paper chromatogram obtained when sodium 5' -ribonucleotide is analysed using the procedure described for “other nucleotides” in the monograph for disodium guanylate contained in the Food Chemicals Codex 1981 at page 105 shall show no spots other than those for guanosine 5' -(disodium phosphate) and inosine 5' -(disodium phosphate).
The criteria in the monograph for glycine contained in the Food Chemicals Codex 1972 at page 359.
SynonymDimethyl silicone.
AppearanceClear colourless odourless liquid free from extraneous matter.
Solubility

  • Insoluble in water.

  • Soluble in most aliphatic and aromatic hydrocarbon solvents.

Volatile matterNot more than 2 per centum (determined by drying at 200°C for 4 hours).
IdentificationShall comply with the identification tests in the monograph for dimethicone in the British Pharmaceutical Codex 1973 at page 168.
AcidityShall comply with the requirement for acidity in the monograph for dimethicone in the British Pharmaceutical Codex 1973 at page 168.
Total siliconNot less than 37.3 and not more than 38.5 per centum.
Refractive index n 25°C DNot less than 1.400 and not more than 1.405.
Viscosity (25°C)Not less than 300 and not more than 1050 centistokes.
Relative density d 20°C 4°CNot less than 0.960 and not more than 0.980.
The criteria in the monograph for carnauba wax contained in the Food Chemicals Codex 1972 at page 170.
The standard for machine-made shellac contained in British Standard 3722:1964.
The standard for nitrogen type 2 contained in British Standard 4366:1968.
The criteria in the monograph for nitrous oxide contained in the European Pharmacopoeia Vol. II 1971 at page 316.
The criteria in the monograph for oxygen contained in the European Pharmacopoeia Vol. II 1971 at page 328.
The aqueous extract of the product complying with the monograph for Quillaia or for powdered Quillaia, in each case, contained in the British Pharmacopoeia 1980, at page 382.
DescriptionPolydextrose is an off-white to light tan coloured, water-soluble powder. It consists of a randomly bonded condensation polymer produced by the reaction of D-glucose with sorbitol and citric acid. Free acid groups may be neutralised with potassium hydroxide.
ContentNot less than 90% of polymer on an ash-free and water-free basis.
Free glucoseNot more than 4% of an ash-free and water-free basis.
Free 1,6 anhydro-D-glucoseNot more than 4% on an ash-free and water-free basis.
Free sorbitalNot more than 2% on an ash-free and water-free basis.
WaterNot more than 4% (Karl Fischer).
pH (10% aqueous solution)Not less than 2.5 and not more than 3.5 (not less than 5.0 and not more than 6.0 for the neutralised product).
Sulphated ashNot more than 0.3% (not more than 3.0% for the neutralised product).
ArsenicNot more than 1 mg/kg.
LeadNot more than 1 mg/kg.
  1. E 170(i)Calcium carbonate
  2. E 200Sorbic acid
  3. E 202Potassium sorbate
  4. E 203Calcium sorbate
  5. E 210Benzoic acid
  6. E 211Sodium benzoate
  7. E 212Potassium benzoate
  8. E 213Calcium benzoate
  9. E 214Ethyl p-hydroxybenzoate
  10. E 215Sodium ethyl p-hydroxybenzoate
  11. E 216Propyl p-hydroxybenzoate
  12. E 217Sodium propyl p-hydroxybenzoate
  13. E 218Methyl p-hydroxybenzoate
  14. E 219Sodium methyl p-hydroxybenzoate
  15. E 220Sulphur dioxide
  16. E 221Sodium sulphite (anhydrous or heptahydrate)
  17. E 222Sodium hydrogen sulphite
  18. E 223Sodium metabisulphite
  19. E 224Potassium metabisulphite
  20. E 226Calcium sulphite
  21. E 227Calcium hydrogen sulphite
  22. E 228Potassium hydrogen sulphite
  23. E 230Biphenyl, diphenyl
  24. E 231Orthophenyl phenol
  25. E 232Sodium orthophenyl phenol
  26. E 233Thiabendazole
  27. E 234Nisin
  28. E 239Hexamethylene tetramine
  29. E 249Potassium nitrite
  30. E 250Sodium nitrite
  31. E 251Sodium nitrate
  32. E 252Potassium nitrate
  33. E 260Acetic acid
  34. E 261Potassium acetate
  35. E 262(i)Sodium acetate
  36. E 262(ii)Sodium diacetate
  37. E 263Calcium acetate
  38. E 270Lactic acid
  39. E 280Propionic acid
  40. E 281Sodium propionate
  41. E 282Calcium propionate
  42. E 283Potassium propionate
  43. E 290Carbon dioxide
  44. E 296Malic acid
  45. E 297Fumaric acid
  46. E 300Ascorbic acid
  47. E 301Sodium ascorbate
  48. E 302Calcium ascorbate
  49. E 304Fatty acid esters of ascorbic acid
  50. E 304(i)Ascorbyl palmitate
  51. E 306Tocopherol-rich extract
  52. E 307Alpha-tocopherol
  53. E 308Gamma-tocopherol
  54. E 309Delta-tocopherol
  55. E 310Propyl gallate
  56. E 311Octyl gallate
  57. E 312Dodecyl gallate
  58. E 320Butylated hydroxyanisole (BHA)
  59. E 321Butylated hydroxytoluene (BHT)
  60. E 322Lecithins
  61. E 325Sodium lactate
  62. E 326Potassium lactate
  63. E 327Calcium lactate
  64. E 330Citric acid
  65. E 331(i)Monosodium citrate
  66. E 331(ii)Disodium citrate
  67. E 331(iii)Trisodium citrate
  68. E 332(i)Monopotassium citrate
  69. E 332(ii)Tripotassium citrate
  70. E 333(i)Monocalcium citrate
  71. E 333(ii)Dicalcium citrate
  72. E 333(iii)Tricalcium citrate
  73. E 334L-(+)-Tartaric acid
  74. E 335(i)Monosodium L-(+)-tartrate
  75. E 335(ii)Disodium L-(+)-tartrate
  76. E 336(i)Monopotassium L-(+)-tartrate
  77. E336(ii)Dipotassium L-(+)-tartrate
  78. E 337Sodium potassium L-(+)-tartrate
  79. E 338Phosphoric acid
  80. E 339(i)Monosodium phosphate
  81. E 339(ii)Disodium phosphate
  82. E 339(iii)Trisodium phosphate
  83. E 340(i)Monopotassium phosphate
  84. E 340(ii)Dipotassium phosphate
  85. E 340(iii)Tripotassium phosphate
  86. E 341(i)Monocalcium phosphate
  87. E 341(ii)Dicalcium phosphate
  88. E 340(iii)Tricalcium phosphate
  89. E 350(i)Sodium malate
  90. E 350(ii)Sodium hydrogen malate
  91. E 351Potassium malate
  92. E 352(i)Calcium malate
  93. E 352(ii)Calcium hydrogen malate
  94. E 353Metatartaric acid
  95. E 355Adipic acid
  96. E 363Succinic acid
  97. E 380Triammonium citrate
  98. E 385Calcium disodium ethylenediamine — N N N'N' — tetra-acetate
  99. E 400Alginic acid
  100. E 401Sodium alginate
  101. E 402Potassium alginate
  102. E 403Ammonium alginate
  103. E 404Calcium alginate
  104. E 405Propane-1,2-diol alginate
  105. E 406Agar
  106. E 407Carrageenan
  107. E 410Locust bean gum
  108. E 412Guar gum
  109. E 413Tragacanth
  110. E 414Acacia
  111. E 415Xanthan gum
  112. E 416Karaya gum
  113. E 420(i)Sorbitol
  114. E 420(ii)Sorbitol syrup
  115. E 421Mannitol
  116. E 422Glycerol
  117. E 432Polyoxyethylene (20) sorbitan monolaurate
  118. E 433Polyoxyethylene (20) sorbitan monooleate
  119. E 434Polyoxyethylene (20) sorbitan monopalmitate
  120. E 435Polyoxyethylene (20) sorbitan monostearate
  121. E 436Polyoxyethylene (20) sorbitan tristearate
  122. E 440(i)Pectin
  123. E 440(ii)Amidated pectin
  124. E 442Ammonium phosphatides
  125. E 450(i)Disodium diphosphate
  126. E 450(ii)Trisodium diphosphate
  127. E 450(iii)Tetrasodium diphosphate
  128. E 450(v)Tetrapotassium diphosphate
  129. E 450(vi)Dicalcium diphosphate
  130. E 451(i)Pentasodium triphosphate
  131. E 451(ii)Pentapotassium triphosphate
  132. E 452(i)Sodium polyphosphate
  133. E 452(ii)Potassium polyphosphate
  134. E 452(iv)Calcium polyphosphates
  135. E 460(i)Microcrystalline cellulose
  136. E 460(ii)Powdered cellulose
  137. E 461Methylcellulose
  138. E 463Hydroxypropylcellulose
  139. E 464Hydroxypropylmethylcellulose
  140. E 465Ethylmethylcellulose
  141. E 466Carboxymethylcellulose
  142. E 470aSodium, potassium and calcium salts of fatty acids
  143. E 471Mono- and diglycerides of fatty acids
  144. E 472(a)Acetic acid esters of mono- and diglycerides of fatty acids
  145. E 472(b)Lactic acid esters of mono- and diglycerides of fatty acids
  146. E 472(c)Citric acid esters of mono- and diglycerides of fatty acids
  147. E 472(d)Tartaric acid esters of mono- and diglycerides of fatty acids
  148. E 472(e)Mono-and diacetyl tartaric acid esters of mono- and diglycerides of fatty acids
  149. E 472(f)Mixed acetic and tartaric acid esters of mono- and diglycerides of fatty acids
  150. E 473Sucrose esters of fatty acids
  151. E 474Sucroglycerides
  152. E 475Polyglycerol esters of fatty acids
  153. E 476Polyglycerol polyricinoleate
  154. E 477Propane-1,2-diol esters of fatty acids
  155. E 481Sodium stearoyl-2-lactylate
  156. E 482Calcium stearoyl-2-lactylate
  157. E 483Stearyl tartrate
  158. E 491Sorbitan monostearate
  159. E 492Sorbitan tristearate
  160. E 493Sorbitan monolaurate
  161. E 494Sorbitan monooleate
  162. E 495Sorbitan monopalmitate
  163. E 500(i)Sodium carbonate
  164. E 500(ii)Sodium hydrogen carbonate
  165. E 500(iii)Sodium sesquicarbonate
  166. E 501(i)Potassium carbonate
  167. E 501(ii)Potassium hydrogen carbonate
  168. E 503(i)Ammonium carbonate
  169. E 503(ii)Ammonium hydrogen carbonate
  170. E 504Magnesium carbonates
  171. E 507Hydrochloric acid
  172. E 508Potassium chloride
  173. E 509Calcium chloride
  174. E 513Sulphuric acid
  175. E 514(i)Sodium sulphate
  176. E 515(i)Potassium sulphate
  177. E 516Calcium sulphate
  178. E 522Aluminium potassium sulphate
  179. E 524Sodium hydroxide
  180. E 525Potassium hydroxide
  181. E 526Calcium hydroxide
  182. E 527Ammonium hydroxide
  183. E 528Magnesium hydroxide
  184. E 529Calcium oxide
  185. E 530Magnesium oxide
  186. E 535Sodium ferrocyanide
  187. E 536Potassium ferrocyanide
  188. E 541Sodium aluminium phosphate, acidic
  189. E 551Silicon dioxide
  190. E 552Calcium silicate
  191. E 553a(i)Magnesium silicate
  192. E 553a(ii)Magnesium trisilicate
  193. E 553bTalc
  194. E 554Sodium aluminium silicate
  195. E 556Calcium aluminium silicate
  196. E 559Aluminium silicate (Kaolin)
  197. E 575Glucono-delta-lactone
  198. E 576Sodium gluconate
  199. E 577Potassium gluconate
  200. E 578Calcium gluconate
  201. E 621Monosodium glutamate
  202. E 627Disodium guanylate
  203. E 631Disodium inosinate
  204. E 635Disodium 5' -ribonucleotides
  205. E 640Glycine
  206. E 900Dimethylpolysiloxane
  207. E 901Beeswax, white and yellow
  208. E 903Carnauba wax
  209. E 904Shellac
  210. E 941Nitrogen
  211. E 942Nitrous oxide
  212. E 948Oxygen
  213. E 950Acesulfame potassium
  214. E 951Aspartame
  215. E 953Isomalt
  216. E 957Thaumatin
  217. E 959Neohesperidine DC
  218. E 965(i)Maltitol
  219. E 965(ii)Maltitol syrup
  220. E 966Lactitol
  221. E 967Xylitol
  222. E 999Extract of Quillaia
  223. E 1200Polydextrose

Annotations

Footnotes

f1

O.J. No. L352, 13.12.86, p. 45

f2

O.J. No. L326, 24.11.90, p. 58

f3

O.J. No. L55, 29.2.92, p. 96