TEST

SPECIFICTIONS

Description

A white or almost white,amorphous powder;hygroscopic

Identification

According to the requirements

Water content

≤3.0%

15-epimer

≤0.5%

5,6-trans isomer

≤1.0%

Other max single impurity

≤1.0%

Total impurities

≤2.5%

  Residue solvents

Diethyl ether≤0.5%

Methanol≤0.3%

Acetone≤0.5%

Tetrahydrofuran≤0.072%

Ethyl acetate≤0.5%

Dichloromethane≤0.06%

Purity (HPLC)

≥98.5%

Assay (HPLC)

97.5~102.5%