Listing ID #4245730
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ITEMS | SPECIFICATIONS | RESULTS |
---|---|---|
Description | White or almost white crystalline powder |
Almost white crystalline powder |
Solubility | Freely soluble in Chloroform Sparingly soluble in anhydrous ethanol Slightly soluble in acetonitrile Practically insoluble in water |
Conforms |
HPLC UV IR |
Must conform to reference standard Must conform to reference standard Must conform to reference standard |
Conforms Conforms Conforms |
Loss on drying | Not more than 0.5% | 0.0006 |
Chloride | Not more than 0.035% | <0.035% |
Residue on ignition | Not more than 0.1% | 0.0003 |
Heavy metals | Not more than 10 ppm | <10 ppm |
Ethyl candesartan Desethyl candesartan Other Individual impurity Total impurities |
Not more than 0.3% Not more than 0.3% Not more than 0.1% Not more than 1.0% |
0.11% 0.15% 0.05% 0.37% |
Ethanol Acetone Ethyl acetate Dichloromethane N, N-Dimethylformamide n-Heptane Acetic acid |
Not more than 0.5% Not more than 0.5% Not more than 0.5% Not more than 0.06% Not more than 0.088% Not more than 0.5% Not more than 0.3% |
Conforms 0.004% Conforms Conforms Conforms Conforms Conforms |
Assay | 98.0~102.0% | 0.9865 |