Olanzapine

TESTS 

        STANDARD 

Appearance

Yellow crystal or crystalline powder

Identification

1. A.    The IR spectrum corresponds to reference standard
2. B.     The retention time of the major peak of the sample solution corresponds to that of the standard solution as obtained in the assay

Related compounds

Impurity A≤0.1%

Impurity B≤0.1%

Chloromethyl olanzapinium chloride ≤0.15%

Any individual unspecified impurity ≤0.1%

Total impurities ≤0.4%

Water

≤1.0%

Residue on ignition

≤0.1%

Heavy metals

≤0.001%

Residual solvents

Ethanol ≤5000ppm

Dimethyl sulfoxide ≤5000ppm

Toluene ≤890ppm

Assay  

98-102.0%