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Candesartan cilexetil

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 A  0.15%
Inpurity B  0.3%
Inpurity F   0.2%
Inpurity G   0.2%
Inpurity H   0.15%
Total impurities 0.6%
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