TEST ITEMS

       SPECIFICATION

RESULTS

Description

White Crystalline Powder

White Powder

Identification

Positive

Positive

Assay(by HPLC)

98.0~102.0%

98.64%

Absorbance(E1cm)

465~495

482.5

Melting Point

191~195°C

193.5~195.0°C

Loss On Drying

0.5%max

0.19%

Specific Rotation

+288°~ +298°

+290.2°

Residue On Ignition

0.1%max

0.03%

Related Substances

Total:1.5%max

<1.3%

Single:0.5%max

<0.4%

Residue Solvents

0.2%max

0.10%

Heavy Metals

20PPm max

<10PPm

Conclusion

The specification conform with enterprise standard.