Glipizide

Tests

Specifications

Results

Appearance

White or almost white crystalline powder

White crystalline powder

Identification

IR: The IR absorption spectrum of sample corresponds to that of reference one

Complies

Loss on drying

Not more than 0.5%

0.1%

Residue on ignition

Not more than 0.2%

0.03%

Related substances

              Impurity A

             Impurity X3

Unspecified impurity

Total impurities

Not more than 0.3%

Not more than 0.15%

Not more than 0.10%

Not more than 0.5%

0.10%

0.08%

0.04%

0.26%

Impurity B

Not more than 0.01%

N.D

Assay

98.0%~102.0%

( Calculated on dried basis)

99.4%

Conclusion

Complies with EP7.0