Items

Standard

Results

Description

white to off-white powder

complies

Identification(IR,HPLC)

complies with the standard  

complies

Melting point

about 220℃

220.6℃

Specific rotation

+56°～ +62°   

+59.0°

Loss on drying

max.0.5%   

0.23%

Residue on ignition

max.0.1%   

0.08%

Heavy Metals  

max.30ppm  

complies

Chromatographic purity

Max Single impurity 

max.0.1%  

complies

Total impurities                 

max.2.0%

complies

Assay

97.0%～102.0%   

99.52%

Conclusion: The product complies with the requirements of USP38