Items

Standard

Result

Appearance

White to off-white powder

Conform  

Identification

A.    IR

B.     HPLC

Conform

Conform

Melting point

About 220℃

221.4℃

Specific rotation

+56°~ +62°

59.5°

Loss on drying

0.5% max

0.19%

Residue on ignition

0.1% max

0.07%

Heavy metals

30ppm max

Conform

Chromatographic purity

Single impurity    1.0% max

Total impurities    2.0% max

Conform

Assay

97.0~102.0%

99.45%

Particle size

90%＜50μm

Conform

Conclusion

Conform with USP35