Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
1221181 | Journal of Pharmaceutical and Biomedical Analysis | 2011 | 6 Pages |
Abstract
Impurities found in stressed and stability studies of Olanzapine (polymorphic form-I) [1], [2], [3], [4], [5], [6] and [7] in both drug substance and drug product are described. These impurities are identified as 4-(4-methyl-1-piperazinyl)-3-hydroxymethylidene-1H-benzo[b][1,4]diazepine-2(3H)-thione (hydroxymethylidene thione) and (Z)-4-(4-methyl-1-piperazinyl)-3-acetoxymethylidene-1H-benzo[b][1,4]diazapine-2(3H)-thione (acetoxymethylidene thione). An oxidative degradation pathway of Olanzapine, for the formation of these impurities, has been proposed.
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Authors
P. Sreenivasa Rao, Uttam Kumar Ray, S.G. Hiriyanna, Sumathi V. Rao, Hemant Kumar Sharma, Vijay Kumar Handa, K. Mukkanti,