Candesartan cilexetil 145040-37-5

Items

Specifications

Results

Appearance

A white or almost white powder

White powder

Identification-IR

Complies with the reference spectrum

Complies

Identification- UV

Maximal  absorptions   at    254nm,

minimum absorption at 242nm

Complies

Water

≤ 0.3%

0.19%

Residual solvents

Methanol

≤ 3000ppm

Not found

Ethanol

≤ 5000ppm

Not found

Ethyl ether

≤ 5000ppm

68ppm

Acetone

≤ 5000ppm

482ppm

Ethyl acetate

≤ 5000ppm

Not found

Dichloromethane

≤ 600ppm

Not found

Dimethylformamide

≤ 880ppm

Not found

Related substances

Impurity A

≤ 0.15%

< 0.05%

Impurity B

≤ 0.3%

< 0.05%

Impurity F

≤ 0.2%

< 0.05%

Impurity G

≤ 0.2%

< 0.05%

Impurity H

≤ 0.15%

Not found

Other individual impurity

≤ 0.10%

0.04%

Total impurities

≤ 0.6%

0.21%

Sulfated ash

≤ 0.1%

0.06%

Heavy metals

≤ 10ppm

<10ppm

Assay (Dried substance)

99.0~101.0%

99.8%

Conclusion:

The product complies with EP 9.0