Item

Specification

Result

Characters

Appearance

White or almost white, crystalline powder

White crystalline powder

Solubility  Test

Free soluble in methanol, soluble in ethanol,sparingly soluble in acetone, acetonitrile and chloroform and very slightly soluble in water.

Complies

Identification  

UV

The UV absorption of 0.001% solution in HCl exhibits a max at about 222nm and 283nm.

Complies

HPLC

Should be concordant to the retention time of working standard.

Complies

Tests

Melting Point

136°C – 141°C

136.8°C – 138°C

Specific Rotation

(on dried basisi, 1%solution in chloroform)

-48~-54°

-51.15°

Loss on Drying

(Dry it at 80℃ in vacuum till a constant weight)

NMT 0.5%

0.13%

Residue on ignition

NMT 0.1%

0.08%

Heavy metals

NMT 10ppm

Less than 10ppm

Related substances(by HPLC)

Max single impurity

Total impurity

NMT 0.5%

NMT 1.0%

0.10%

0.19%

Assay (By Titrate)

NLT 98.5%

99.98%

Conclusion

It complies with the requirements of Mediking Standard.

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