CP2010

類白色粉末

Appearance White or almost white powder
Solubility Very soluble in water, slightly soluble in ethanol, insoluble in ethyl ether
Specific optical rotation +206-214?
Absorbance E1%1cm 190-210
Identification HPLC: The retention time of the major peak correspond to that of the standard IR: Conforms to the reference spectrum
Responds to the tests for sodium
PH 4.2-7.0
Appearance of solution Clear or not more than opalescent than reference suspension I, Not more intensely colored than reference solution Y or GY8
Related substance Individual impurity: 0.5% max
Total impurities: 4.0% max
Limit of residual solvents Methanol: 0.3% max
Ethanol: 0.5% max
Acetonitrile: 0.041% max
Acetone: 0.5% max
Ethyl acetate: 0.5% max
Tetrahyrofuran: 0.072% max
Water 1.0% max
Heavy metals 20ppm max
Visible particles Meets the requirement
Sub-visible particles 10μm: 6000particles/g max
25μm: 600 particles/g max
Bacterial endotoxins 0.10EU/mg max
Assay, on dry base 90.1%min