Synthesis and characterization of potential impurities of Oxcarbazepine drug substance: An antiepileptic agent

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.