Commission Regulation (EU) No 231/2012

Contents

E 421 (i) MANNITOL BY HYDROGENATION

Synonyms	D-mannitol
Definition	Manufactured by catalytic hydrogenation of carbohydrate solutions containing glucose and/or fructose.The product contains min. 96 % mannitol. The part of the product which is not mannitol is mainly composed of sorbitol (2 % max), maltitol (2 % max) and isomalt (1,1 GPM (1-O-alpha-D-Glucopyranosyl-D-mannitol dehydrate): 2 % max and 1,6 GPS (6-O-alpha-D- Glucopyranosyl-D-Sorbitol): 2 % max). Unspecified impurities shall not represent more than 0,1 % of each.
Einecs	200-711-8
Chemical name	D-mannitol
Chemical formula	C₆H₁₄O₆
Molecular weight	182,2
Assay	Content not less than 96,0 % D-mannitol and not more than 102 % on the dried basis
Description	White, odourless, crystalline powder
Solubility	Soluble in water, very slightly soluble in ethanol, practically insoluble in ether
Melting range	Between 164 and 169 °C
Infrared absorption spectrometry	Comparison with a reference standard e.g. EP or USP
Specific rotation	[α]_D²⁰ + 23° to + 25° (borate solution)
pH	Between 5 and 8. Add 0,5 ml of a saturated solution of potassium chloride to 10 ml of a 10 % w/v solution of the sample, then measure the pH
Water content	Not more than 0,5 % (Karl Fischer Method)
Conductivity	Not more than 20 μS/cm (on 20 % dry solids solution) at temperature 20 °C
Reducing sugars	Not more than 0,3 % (expressed as glucose)
Total sugars	Not more than 1 % (expressed as glucose)
Nickel	Not more than 2 mg/kg
Lead	Not more than 1 mg/kg

Synonyms	D-mannitol
Definition	Manufactured by discontinuous fermentation under aerobic conditions using a conventional strain of the yeast Zygosaccharomyces rouxii. The part of the product which is not mannitol is mainly composed of sorbitol, maltitol and isomalt.
Einecs	200-711-8
Chemical name	D-mannitol
Chemical formula	C₆H₁₄O₆
Molecular weight	182,2
Assay	Not less than 99 % on the dried basis
Description	White, odourless crystalline powder
Solubility	Soluble in water, very slightly soluble in ethanol, practically insoluble in ether
Melting range	Between 164 and 169 °C
Infrared absorption spectrometry	Comparison with a reference standard e.g. EP or USP
Specific rotation	[α]_D²⁰ + 23° to + 25° (borate solution)
pH	Between 5 and 8Add 0,5 ml of a saturated solution of potassium chloride to 10 ml of a 10 % w/v solution of the sample, then measure the pH
Arabitol	Not more than 0,3 %
Water content	Not more than 0,5 % (Karl Fischer Method)
Conductivity	Not more than 20 μS/cm (on 20 % dry solids solution) at temperature 20 °C
Reducing sugars	Not more than 0,3 % (expressed as glucose)
Total sugars	Not more than 1 % (expressed as glucose)
Lead	Not more than 1 mg/kg
Aerobic mesophilic bacteria	Not more than 1000 colonies per gram
Coliforms	Absent in 10 g
Salmonella spp.	Absent in 25 g
Escherichia coli	Absent in 10 g
Staphylococcus aureus	Absent in 10 g
Pseudomonas aeruginosa	Absent in 10 g
Moulds	Not more than 100 colonies per gram
Yeasts	Not more than 100 colonies per gram