ITEM

SPECIFICATIONS

RESULTS

Appearance

White to off-white crystal powder

White crystal powder

Identification

IR:similar to the reference standard

Complies

Solubility

Soluble in alcohol and in propylene glycol. Sparingly soluble in methanol,slightly soluble in water. Practically insoluble in chloroform,in acetone,in ethyl acetate,and in hexane

Complies

Residue on ignition

≤0.5%

0.02%

Heavy metals

≤20ppm

Complies

Loss on drying

≤0.5%

0.08%

Total impurities

≤1.5%

Conforms

Assay （HPLC）

97～103%

99.49%

Conclusion: Conforms to the standard of USP38