usp
appearance white crystalline powder
solubility freely soluble in methanol, ethanol, ethylacetate and chloroform, slightly soluble in water and 0.1m hydrochloric acid solution
identification ir,hplc
water 0.3% max
residue on ignition 0.1% max
heavy metals 0.001% max
related substances related compound b: 0.2% max
related compound c: 0.2% max
related compound d: 0.1% max
related compound e: 0.1% max
individual unspecified impurity: 0.1% max
total unspecified impurity: 0.2% max
total impurities: 0.5% max
residual solvents dichloromethane: 0.06% max
chloroform: 0.006% max
ethanol: 0.5% max
cyclohexane: 0.08%
ethylacetate: 0.5% max
assay(on dry basis) 98.0%~102.0%