ITEM

SPECIFICATIONS

RESULTS

Appearance

White or almost white crystalline powder

White crystalline powder

Solubility

Practically insoluble in water ,sparingly soluble in anhydrous ethanol ,slightly soluble in methylene chloride.

Complies

Identification

B,C or A,C,D and E

Complies

Specific optical rotation

+86°～+92 °

+90.0°

Related substances

Impurity G  ≤0.3%

0.02%

Impurity B ≤0.15%

0.09%

Impurity F ≤0.15%

Not Detected

Impurity J ≤0.15%

Not Detected

Impurity K ≤0.15%

Not Detected

Unspecified impurity ≤0.1%

0.09%

Total impurities ≤0.5%

0.43%

Loss on Drying

≤0.5%

0.03%

Assay

97.0%～103.0%

(UV,basis on drying)

99.8%

Conclusion: It conforms to the requirements of EP9.0