Items
Specifications
Results
Characteristics
White to off-white, crystalline powder
Conform
Solubility
Soluble in alcohol and acetone, slightly soluble in ether, insoluble in water
Conform
Identification
IR, HPLC
Conform
Specific optical rotation
+57.0°~+63.0°
+57.44°
Melting point
190℃~195.5℃
191.8~195.4℃
Loss on drying
≤0.5%
0.13%
Residue on ignition
≤0.2%
0.06%
Limit of methanol and dichloromethanel
≤0.20%
0.07%
Any impurity
≤1.0%
Conform
Total impurity
≤2.0%
Conform
Assay
97.0%~103.0%
99.28%
Conclusion
The Results conform to USP36