TEST

SPECIFICTIONS

Description

White powder

Identification(HPLC)

RT of sample should match with standard in the Related substances

Water content

≤1.0%

Specific rotation

+33.0°~+39.0°

Residue on ignition

≤0.1%

15-Keto derivative

≤0.5%

5,6-trans isomer

≤0.5%

Other max single impurity

≤0.5%

Total other impurities

≤0.5%

  Residue solvents

Acetonitrile≤0.041%

Diethyl ether≤0.5%

Methanol≤0.3%

Toluene≤0.089%

Tetrahydrofuran≤0.072%

Ethyl acetate≤0.5%

Dichloromethane≤0.06%

Assay

≥99.0%

Conclusion:

Complies with In-house standards