TEST
SPECIFICTIONS
RESULTS
Description
White powder
Complies
Identification(HPLC)
RT of sample should match with standard in the Related substances
Solubility
Freely soluble in methanol, ethanol, ethyl acetate; practically insoluble in water
Water content
≤1.0%
0.25%
15-epimer
≤0.2%
0.19%
5,6-trans isomer
N.D
Other max single impurity
≤0.1%
Total other impurities
≤0.5%
Residue solvents
n-Hexane≤0.029%
Ethanol≤0.5%
Methanol≤0.3%
Toluene ≤0.089%
Tetrahydrofuran≤0.072%
Ethyl acetate≤0.5%
0.06%
Dichloromethane ≤0.06%
Purity
≥99.0%
99.81%
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