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E 459 Beta-cyclodextrin - EU specification

COMMISSION REGULATION (EU) No 231/2012 of 9 March 2012



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


Virtually odourless white or almost white crystalline solid

Appearance of the aqueous solution: Clear and colourless


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)


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