Items
Specifications
Results
Appearance
A white to off- white,amorphous powder;hygroscopic
A white amorphous powder;hygroscopic
Identification
IR: IR of the sample should match with standard
Conform
Sodium Salt
Water content
≤3.0 %
0.29%
15-epimer
≤1.0 %
N.D
5,6-trans isomer
0.01%
Other maximum single impurity
≤0.3%
Total impurities
≤1.5 %
0.20%
Residual solvents
Methanol≤0.3%
Ethanol≤0.5 %
n-Hexane≤0.029 %
Toluene≤0.089 %
Tert-Butyl methyl ether≤0.5 %
Acetone≤0.3%
0.06%
0.10%
Assay (on the anhydrous basis)
97.5 %~102.5%
99.5%
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