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GST No. 24ABMFA3019J1ZKAsk for more detail from the seller
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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 |
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