ANNEXSupplementary provisions
ANNEX SPECIFICATIONS OF γ-CYCLODEXTRIN Synonyms γ-cyclodextrin, γ-dextrin, cyclooctaamylose, cyclomaltooctaose, γ-cycloamylase Definition A non-reducing cyclic saccharide consisting of eight α-1,4-linked D-glucopyranosyl units produced by the action of cyclodextrin glucosyltransferase (CGTase, EC 2.4.1.19) on hydrolysed starch. Recovery and purification of γ-cyclodextrin may be carried out by precipitation of a complex of γ-cyclodextrin with 8-cyclohexadecen-1-one, dissolution of the complex with water and n-decane, steam-stripping of the aqueous phase and recovery of gamma-CD from the solution by crystallisation. Chemical name Cyclooctaamylose CAS number 17465-86-0 Chemical formula (C 6 H 10 O 5 ) 8 Structural formula Assay Not less than 98 % (dry basis) Description Virtually odourless, white or almost white crystalline solid Characteristics Identification Melting range Decomposes above 285 °C Solubility Freely soluble in water; very slightly soluble in ethanol Specific rotation [α] D 25 : between + 174° and + 180° (1 % solution) Purity Water Not more than 11 % Residual complexant (8-cyclohexadecen-1-one (CHDC) Not more than 4 mg/kg Residual solvent (n-decane) Not more than 6 mg/kg Reducing substances Not more than 0,5 % (as glucose) Sulphated ash Not more than 0,1 %