Test items

Specifications

Appearance

A white or almost white crystalline powder, very soluble in methylene chloride freely soluble in ethanol(96%), paratactically in soluble in water 

Identification

IR should be conformed

HPLC should be conformed

Specific optical rotation

+285°~ +298°

Heavy metals

≤20ppm

Loss on drying

≤0.5%

Sulphated ash

≤0.1%

Assay 

97.0%~102.0%

Chromatography purity

Impurity A

Impurity B+C

Impurity D

Impurity E+F

ImpurityG

Any other individual impurity

Total impurities

(Excluding impurity E+F)

≤0.4%

≤0.8%

≤0.4%

≤1.0%

≤0.4%

≤0.10%

≤1.0%

Residual organic solvents

Methanol

Ethanol

Methylene chloride

≤3000ppm

≤5000ppm

≤600ppm