TEST ITEM

SPECIFICATION

RESULTS

Characteristics

White or almost white crystalline powder.

A white crystal powders

Identification

C.  An intense blue color develops

C. An intense blue color develops

Solubility

Very slightly soluble in water, soluble in methanol, sparingly soluble in methylene chloride, slightly soluble in alcohol.

Very slightly soluble in water,soluble in methanol, sparingly soluble in methylene chloride, slightly soluble in alcohol.

Melting point

About 165 °C, with decomposition

165-166.8°C

Related substances

impurity A: 0.2%max

0.04%

impurity B:0.2%max

0.06%

impurity C:0.2%max

0.04%

Total: 0.3%max

0.14%

disregard limit:0.05%max

0.05%max

Loss on drying

Not more than 0.5%

≤0.5%

0.05%

Chromatographic purity

Not more than 2.0%

≤2.0%

2.0%max

Sulphated ash

Not more than 0.1%

 ≤0.1%

0.02%

Residual solvents

Meet the requirements

Meet the requirements

Assay

98.5%-101.0%

100.1%

Remark:

PARTICLE SIZE: 100% pass 30micron

CONCLUSION: Conform With  BP2007/USP31