E 459 BETA-CYCLODEXTRIN

Commission Directive 2003/95/EC

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

Chemical name Cycloheptaamylose

EINECS 231-493-2

Chemical formula (C₆H₁₀O₅)₇

Molecular weight 1135

Assay Content not less than 98,0 % of (C₆H₁₀O₅)₇ on an anhydrous basis

Description Virtually odourless, white or almost white crystalline solid

Identification

A. Solubility Sparingly soluble in water; freely soluble in hot water; slightly soluble in ethanol

B. Specific rotation [α]²⁵_D: + 160º to + 164º (1 % solution)

Purity

Water Not more than 14 % (Karl Fischer method)

Other cyclodextrins Not more than 2 % on an anhydrous basis

Residual solvents (toluene and trichloroethylene) Not more than 1 mg/kg for each solvent

Sulphated ash Not more than 0,1 %

Arsenic Not more than 1 mg/kg

Lead Not more than 1 mg/kg