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.