COMMISSION REGULATION (EU) No 231/2012 of 9 March 2012
Synonyms
Definition
Beta-cyclodextrin is a non-reducing cyclic saccharide consisting of seven α-1,4-linked D-glucopyranosyl units. The product is manufactured by the action of the enzyme cycloglycosyltransferase (CGTase) obtained from Bacillus circulans, Paenibacillus macerans or recombinant Bacillus licheniformis strain SJ1608 on partially hydrolysed starch
Einecs: 231-493-2
Chemical name: Cycloheptaamylose
Chemical formula: (C 6 H 10 O 5 ) 7
Molecular weight: 1 135
Assay: Content not less than 98,0 % of (C 6 H 10 O 5 ) 7 on an anhydrous basis
Description
Virtually odourless white or almost white crystalline solid
Appearance of the aqueous solution: Clear and colourless
Identification
Solubility Sparingly soluble in water; freely soluble in hot water; slightly soluble in ethanol
Specific rotation: [α] D 25 + 160° to + 164° (1 % solution)
pH value: 5,0-8,0 (1 % solution)
Purity
Water content: Not more than 14 % (Karl Fischer method)
Other cyclodextrins: Not more than 2 % on an anhydrous basis
Solvent residues: Not more than 1 mg/kg of each of toluene and trichloroethylene
Sulphated ash: Not more than 0,1 %
Arsenic: Not more than 1 mg/kg
Lead: Not more than 1 mg/kg