TEST

SPECIFICATIONS

RESULTS

Description

White or almost white crystalline powder

White crystalline powder

Solubility

Free soluble in Chloroform and in alcohol,very slightly soluble

in water

Complies

Assay

98.0% ~ 102.0%

99.16%

Identification (IR)

Complies with the standard

Complies

Loss on drying

≤0.5%

0.15%

Residue on ignition

≤0.1%

0.06%

Heavy metals (Method II)

≤10 ppm

Complies

Impurity A: ≤0.3%

0.10%

not detected

0.10%

complies 0.26%

Related substances (HPLC)

Impurity B: ≤0.3% Impurity C: ≤0.3%

Other single impurity: ≤0.1%

Total impurities: ≤0.6%

Specific rotation

+12.0°~ +14.0°

+13.15°