Synthesis and characterization of potential impurities of Oxcarbazepine drug substance: An antiepileptic agent |
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| Authors: | Siva Rama Kasibabu Velugula Aaramadaka Sunil Kumar Reddy Nimesh Chandra Misra Pindi Santhosh Reddy Ramadas Chavakula Anil Kumar Guduri Paul Douglas Sanasi |
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| Institution: | 1. Chemical Research Department, APL Research Centre-II, Aurobindo Pharma Limited, Indrakaran, India;2. Department of Engineering Chemistry, A. U. College of Engineering (A), Andhra University, Visakhapatnam, India |
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| Abstract: | Oxcarbazepine is a drug substance used to treat epilepsy. During its bulk synthesis of various impurities formation will be observed. Herein we describe the formation, synthesis and characterization of four potential impurities, namely, N-acetyl Oxcarbazepine, N-formyl Oxcarbazepine, N-carbamoyl Oxcarbazepine, and Oxcarbazepine dimer. These impurities are listed in several Pharmacopoeias and the control of these impurities below the threshold level is essential. Our study will be a guide for making these reference standards. |
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| Keywords: | Oxcarbazepine dimer Oxcarbazepine enamine Oxcarbazepine impurities Oxcarbazepine impurity D |
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