Items

Standard

Results

Appearance

White to practically white,odorless,crystalline powder

white crystalline powder

Identification (A,B)

A:IR     B:UV

Complies

Solubility

Sparingly soluble in acetone,in alcohol,in dioxane,and in methanol,slightly soluble in chloroform;very slightly soluble in ether;practically insoluble in water.

Complies

Melting point

About250℃

253.5℃～254.5℃

Specific Rotation

+72°～+80°

+76.8°

Loss on drying

≤0.5%  

0.06%

Residue on ignition

≤0.2%

0.05%

Chromatographic purity

- any individual impurity

≤1.0%   

0.09%

- total impurities

≤2.0%  

0.36%

Assay(HPLC, basis on drying)

97.0%～102.0%    

98.1%

Particle Size

100%＜30um

Complies