Items
Specifications
Results
Appearance
A white or almost white amorphous powder;
hygroscopic
White amorphous powder; hygroscopic
Solubility
Free soluble in water,in ethanol(95%)and in methanol;practically insoluble in acetone
Conforms
Identification
IR,HPLC
White precipitate is observed in characteristic
testing of sodium salts
Water
≤3.0%
0. 12%
Specific Rotation
+ 25 。 ~ + 30 。(C= 1,in Ethanol)
+ 29.5
15-epimer
5,6-trans isomer
(-)-enantiomer
Other single impurity
Total impurities
≤1.0%
≤2.0%
≤0.5% ≤2.5
N.D
0.1%
Residual solvents
Methnol≤0.3%
Tetrahydrofuran≤0.072%
Toluene≤0.089%
Ethyl acetate≤0.5%
Dichloromethane≤0.06%
0.05%
Puirty(HPLC)
≥97.5%
99.9%
Assay
97.5%~ 102.5%
99.5%
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