Superiority:
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%
Details:
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%