Candesartan cilexetil/145040-37-5
FW: 610.6597
Physical Form: White to almost white crystalline powder
Melting Point:167~170°C
| Item of testing | Standard | Result |
| Characters | White or almost white powder | white powder |
| Assay | 99.0~101.0% | 99.6% |
| Solubility | Practically insoluble in water,freely soluble in methylene chloride and slightly soluble in anhydrous ethanol. | Corresponds |
| Identification | The IR spectrum is consistent with that obtained with the reference standard | Corresponds |
| Water | NMT 0.3% | 0.22% |
| Sulphated ash | NMT 0.1% | 0.07% |
| Related Substances(HPLC) | Inpurity A0.15% Inpurity B0.3% Inpurity F 0.2% Inpurity G 0.2% Inpurity H 0.15% Total impurities0.6% | Below disregard limit 0.09% 0.11% Not detected Not detected 0.29% |
| Residual solvents(GC) | Methanol NMT 3000ppm Acetone NMT 5000ppm Ethyl acetate NMT 5000ppm n-Heptane NMT 5000ppm Dichloromethane NMT 600ppm Acetic acid NMT 5000ppm | Not detected 48ppm Not detected 46ppm Not detected Not detected |