Lisinopril

Tests

Specifications

Results

Appearance

White or off- white crystalline powder

White crystalline powder

Identification

IR spectrum accordance with that of CRS

Conforms

Solubility

Soluble in water, sparingly soluble in methanol, practically insoluble in acetone and in anhydrous ethanol

Conforms

Specific rotation

-43°~-47°

-45.8°

Water

8.0%~9.5%

8.08%

Sulphated ash

Not more than 0.1%

0.07%

Related substances (HPLC)

Impurity A

Impurity B

Impurity C

Impurity D

Impurity E

Impurity F

Any unspecified impurity

Total impurities

Not more than 0.3%

Not more than 0.3%

Not more than 0.3%

Not more than 0.3%

Not more than 0.3%

Not more than 0.3%

Not more than 0.10%

Not more than 0.5%

<0.05%

No detectable

<0.05%

No detectable

<0.05%

0.07%

0.05%

0.26%

Assay

98.5%~101.5%( Calculated on dried basis)

100.2%

Residual solvents

Acetone

Ethanol

Dichloromethane

Hexane

   Ethyl acetate

Not more than 5000ppm

Not more than 5000ppm

Not more than 600ppm

Not more than 890ppm

Not more than 5000ppm

<75ppm

No detectable

No detectable

No detectable

No detectable

Conclusion

Complies with EP 7.0