# Miscellaneous Food Additives Regulations (Northern Ireland) 1996, Schedule 5: Purity Criteria

Extent: N.I.
Status: prospective

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.
Description
Fine white microcrystalline or amorphous powder
Content
Not less than 97 per centum of CaCO3 on a volatile matter-free basis
Volatile matter
Not more than 1 per centum (determined by drying at 105°C to constant weight)
Matter insoluble in hydrochloric acid
Shall 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
Arsenic
Not more than 5 mg per kg.
Lead
Not more than 20 mg per kg.
Other inorganic impurities
Not 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/EEC.
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.
Synonym
Hexamine
Synonym
Sodium 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
Description
White or nearly white crystalline powder or granules
Content Melting range
Not less than 99 per centum of C4H6O5. 99°C to 101°C.
Specific rotation [α] 20°C D
Not 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.
Synonym
Sodium dihydrogen citrate
Synonym
Potassium dihydrogen citrate
Synonym
Potassium sodium tartrate
Synonym
Orthophosphoric acid
Synonym
Monosodium orthophosphate
Synonym
Disodium orthophosphate Disodium hydrogen orthophosphate
Synonym
Trisodium orthophosphate
Synonyms
Monodipotassium orthophosphate Potassium dihydrogen orthophosphate
Synonyms
Dipotassium orthophosphate Dipotassium hydrogen orthophosphate
Synonym
Tripotassium orthophosphate
Description
Colourless or almost colourless aqueous solution. Sodium malate may be derived from either DL-malic acid or L-malic acid.
Content
Not less than 59.5 per centum of C4H4O5Na2.
Maleic acid
Not more than 0.05 per centum calculated on the C4H4O5Na2 content.
Description
White odourless powder. Sodium hydrogen malate may be derived from either DL-malic acid or L-malic acid.
Content
Not less than 99 per centum of C4H5O5Na on a volatile matter-free basis.
Volatile matter
Not more than 2 per centum (determined by drying at 110°C for 3 hours)
Maleic acid
Not more than 0.05 per centum.
Description
Colourless or almost colourless aqueous solution. Potassium malate may be derived from either DL-malic acid or L-malic acid.
Content
Not less than 59.5 per centum of C4H4O5K2
Maleic acid
Not more than 0.05 per centum calculated on the C4H4O5K2 content.
Description
White odourless powder. Calcium malate may be derived from either DL-malic acid or L-malic acid
Content
Not less than 97.5 per centum of C4H4O5Ca on a volatile matter-free basis.
Volatile matter
Not more than 2 per centum (determined by drying at 110°C for 3 hours)
Maleic acid
Not more than 0.05 per centum.
Fluoride
Not more than 30 mg per kg on a volatile matter-free basis
Description
White odourless powder. Calcium hydrogen malate may be derived from either DL-malic acid or L-malic acid
Content
Not less than 97.5 per centum of (C4H5O5)2Ca on a volatile matter-free basis.
Volatile matter
Not more than 2 per centum (determined by drying at 110°C for 3 hours)
Maleic acid
Not more than 0.05 per centum.
Fluoride
Not more than 30 mg per kg on a volatile matter-free basis
Description
White 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 cm
Not more than 1.5 × 10−2at 430 nm. (determined using a filtered aqueous solution).
Identification
Place 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 D
Not 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 acid
Not 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.
Synonym
Ammonium citrate
The criteria in the monograph for ammonium citrate contained in the British Pharmaceutical Codex 1973 at page 830.
Synonym
Sodium calciumedate
The criteria in the monograph for sodium calciumedetate contained in the British Pharmacopoeia 1973 at page 425.
Synonym
Propylene 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/EEC.
Synonym
Carob gum
Synonym
Gum 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.
Synonym
Sterculia 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.
Synonym
Polysorbate 20
The criteria in the monograph for polysorbate 20 contained in the Food Chemicals Codex 1981 at page 234.
Synonym
Polysorbate 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.
Synonym
Polysorbate 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.
Synonym
Polysorbate 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.
Synonym
Polysorbate 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.
Description
Ammonium 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 phosphatides
Not less than 6.0 and not more than 8.0
Phosphorus
Not less than 3.0 per centum and not more than 3.4 per centum.
Ammonium nitrogen
Not less than 1.2 per centum and not more than 1.5 per centum.
Arsenic
Not more than 5 mg per kg.
Synonyms
Dicalcium 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 phosphate
Not more than 8 per centum calculated on the P2O5 content.
Fluoride
Not 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.
Synonym
Alpha-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.
Synonym
Methylethylcellulose
Synonym
Sodium 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.
Synonym
Acetylated mono- and diglycerides
Synonym
Citroglycerides
Synonym
Mono- 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/EEC.
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
Description
The 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°C
Not less than 1.4630 and not more than 1.4665.
Hydroxyl value
Not less than 80 and not more than 100.
Iodine value
Not less than 72 and not more than 103 (Wijs).
Acid value
Not more than 6 mg KOH per g.
Synonym
Propylene 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.
Description
Colourless crystals or white granular or crystalline powder. The anhydrous salt is hygroscopic and the decahydrate is efflorescent.
Content
Not 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.
Sulphate
Not more than 0.4 per centum on a volatile matter-free basis.
Chloride
Not more than 0.4 per centum on a volatile matter-free basis
Iron
Not more than 40 mg per kg on a volatile matter-free basis.
Synonym
Sodium 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.
Content
Not 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)
Synonym
Potassium 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.
Synonym
Ammonium 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.
Synonyms
Potassium 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.
Description
Soft white powder.
Solubility
1 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.
Content
Not 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 salts
Not 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.
Carbonate
When 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.
Sulphate
Not more than 0.35 per centum.
Fluoride
Not 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.
Synonyms
Sodium hexacyanoferrate (II)
The criteria in the monograph for sodium ferrocyanide contained in the Food Chemicals Codex 1972 at page 741.
Synonym
Potassium hexacyanoferrate (II)
Description
Odourless lemon yellow crystals.
Solubility
Soluble in water and in acetone. Insoluble in ethanol, in ether and in hydrocarbons.
Content
Not less than 98 per centum of K4Fe(CN)6. 3H2O.
Free moisture
Not 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).
Chloride
Not more than 0.1 per centum.
Sulphate
Not 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.
Synonym
Silica, chemically prepared.
Description
Silica 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 matter
Hydrated silica: not more than 7 per centum (determined by drying at 105°C for 2 hours).
Loss on ignition
Not 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.
Description
White 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 matter
Not more than 6 per centum (determined by drying at 105°C for 2 hours).
Loss on ignition
Not 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.
Description
Talc 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.
Description
Fine 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 matter
Not more than 8 per centum (determined by drying at 105°C for 2 hours)
Loss on ignition
Not 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.
Description
Fine 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 matter
Not more than 10 per centum (determined by drying at 105°C for 2 hours).
Loss on ignition
Not less than 14 per centum and not more than 18 per centum (determined by ignition at 1000°C to constant weight).
Synonym
D-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.
Description
White free-flowing powder.
Solubility
Freely soluble in water. Practically insoluble in ethanol and in ether.
Content
Not less than 97 per centum of C6H11O7K on a volatile matter-free basis.
Volatile matter
Not 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.
Formula
C5H8NNaO4.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.
Formula
C10H12N5Na2O8P.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.
Formula
C10H11N4Na2O8P.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.
Content
Not 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.
Moisture
Not 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 acids
Place 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 nucleotides
The 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.
Synonym
Dimethyl silicone.
Appearance
Clear colourless odourless liquid free from extraneous matter.
Solubility
Insoluble in water.
Soluble in most aliphatic and aromatic hydrocarbon solvents.
Volatile matter
Not more than 2 per centum (determined by drying at 200°C for 4 hours).
Identification
Shall comply with the identification tests in the monograph for dimethicone in the British Pharmaceutical Codex 1973 at page 168.
Acidity
Shall comply with the requirement for acidity in the monograph for dimethicone in the British Pharmaceutical Codex 1973 at page 168.
Total silicon
Not less than 37.3 and not more than 38.5 per centum.
Refractive index n 25°C D
Not 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°C
Not 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.
Description
Polydextrose 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.
Content
Not less than 90% of polymer on an ash-free and water-free basis.
Free glucose
Not more than 4% of an ash-free and water-free basis.
Free 1,6 anhydro-D-glucose
Not more than 4% on an ash-free and water-free basis.
Free sorbital
Not more than 2% on an ash-free and water-free basis.
Water
Not 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 ash
Not more than 0.3% (not more than 3.0% for the neutralised product).
Arsenic
Not more than 1 mg/kg.
Lead
Not more than 1 mg/kg.

---
Source: https://www.legislation.gov.uk/nisr/1996/50/schedule/5 (the official version)
Page: https://openlegislation.uk/miscellaneous-food-additives-regulations-northern-ireland-1996/schedule-5
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.