Items

Standard

Results

Description

White or almost white crystalline powder

complies

Identification

A: Infrared Absorption 197M

Complies

B:Thin-Layer Chromatographic Identification Test 201

Complies

Specific Rotation  

between +75 and +82

 +79.5°

Loss on drying

not more than 0.5%

0.07%

Residue on ignition

not more than 0.2%

0.05%

Chromatographic purity(HPLC)    

- any individual impurity

not more than 1.0%

0.38%

- total impurities  

not more than 2.0%

0.85%

Assay（HPLC,on the dried basis）

97.0%～103.0%

100.5%

Additional test

Packaging and storage

Preserve in tight containers

Conclusion

The test product complies with the requirements of USP31