Raw material medicine,145040-37-5,Candesartan cilexetil/Anti hypertension

TEST

STANDARD

RESULT

Characters

A white or almost white crystalline powder

A white crystalline powder

Solubility

Freely soluble in chloroform;

Sparingly soluble in anhydrous ethanol

Slightly soluble in acetonitrile

Practically insoluble in water

Conforms

Identification

1. The retention time is consistent with that obtained with the reference

Conforms

B. The UV spectrum is consistent with that obtained with the reference

Conforms

C. The UV spectrum is consistent with that obtained with the reference

Conforms

Loss on drying

NMT 0.5%

0.22%

Sulphated ash

NMT 0.1%

0.08%

Heavy Metals

NMT 0.001%

<0.001%

Chlorides

NMT 0.035%

<0.035%

Related Substances (HPLC)

Individual known impurity NMT 0.5%

0.08%

Individual unknown impurity NMT 0.1%

0.09%

Total impurities NMT 1.0%

0.26%

Residual solvents (GC)

Methanol NMT 0.3%

Not detected

Acetone NMT 0.5%

Not detected

Ethyl acetate NMT 0.5%

0.007%

n-Heptane NMT 0.5%

Not detected

Dichloromethane NMT 0.06%

Not detected

N,N-Dimethylformamide NMT 0.088%

Not detected

Acetic acid NMT 0.5%

Not detected

Assay (HPLC)

98.0~102.0%

99.24%