A. The IR spectrum corresponds to reference standard.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(HPLC)
Impurity A
NMT 0.10%
Impurity B
NMT 0.10%
Chloromethyl olanzapinium chloride
NMT 0.15%
Any individual unspecified impurity
NMT 0.10%
Total impurities
NMT 0.4%
Water(KF)
NMT 1.0%
Residue on ignition
NMT 1.0%
Heavy metals
NMT 0.001%
Residual solvents(GC)
Ethanol
NMT 5000ppm
Dimethy sulfoxide
NMT 5000ppm
Toluene
NMT 890 ppm
Assay(HPLC)
NLT 98.0%& NMT 102.0%(calculated on the anhydrous and solvents free basis)
