ITEMS

SPECIFICATION

RESULTS

Appearance

A White or almost white crystalline powder 

Conforms

Identification

The infrared absorbance spectrum conforms to the reference spectrum.

Conforms

The retention time of the major peak of the sample solution corresponds to that of the standard solution ,as obtained in the assay.

Conforms

Melting Point

136℃~141℃

136℃~138℃

Loss on drying

≤0.5%

0.13%

Residue on ignition

≤0.1%

0.01%

Phosphate

≤ 0.05%

＜0.05%

Residual solvents

Dichloromethane ≤ 600 ppm

Not detected

Ethanol ≤ 5000ppm

Not detected

Acetone ≤ 5000ppm

174ppm

Related Compounds

A ≤ 0.2 %

0.02%

B ≤ 0.2 %

0.02%

C ≤ 0.2 %

0.002%

Assay(on the dried basis)

98.5% ~ 101.0%

100.2%

Conclusion: Conform to USP41 standard