Description

White crystals or crystalline powder

White crystalline powder

Identification

Infrared absorption uniformity

Conforms

Assay                   

98.5~101.5%

99.3%

Specific optical rotation[a]_D20° 

-84.3°~ -86.3°

-85.6°

Loss on drying               

0.4% max

0.16%

Residue on ignition         

0.4% max

0.08%

Chloride (Cl）        

0.05% max

＜0.05%

Sulfate (SO4)        

0.03% max

＜0.03%

Iron (Fe)            

0.003% max

＜0.003%

Heavy metals（Pb）

0.0015% max

＜0.0015%

Related Compounds  

Individual impuritie

0.5% max

Conforms

Total impurities    

2.0% max

Conforms

Conclusion: Agree with the specification of USP39.