Carbamazepine and its Synthesis Related Impurities Profile Compilation and its Monograph Dispute for the Best Regulatory Practice: A Review

• Published in: Journal of young pharmacists Vol. 12; no. 4; pp. 294 - 298
• Main Authors: Debnath, Samrat, Raju, Jeyaprakash Mari, Chennapragada, Rupika Sunidhi
• Format: Journal Article
• Language: English
• Published: Bangalore InPharm 01-10-2020
• Subjects: Anticonvulsants; Bioavailability; Bipolar disorder; Carcinogens; Convulsions & seizures; Drug stores; Enzymes; Manufacturing; Market entry; Pharmaceuticals; Pharmacists
• ISSN: 0975-1483; 0975-1505
• DOI: 10.5530/jyp.2020.12.80

Carbamazepine (CBZ) is a widely-used anticonvulsant drug, with a high prescription rate. However, there seem to be certain inconsistencies regarding the number of reported impurities of the drug. A monograph study of the drug reveals the difference in the numbers of reported impurities of the drug, i.e., different monographs have reported dissimilar number of impurities for the same drug. Literature survey reveals that over 10 routes of synthesis are currently existing for the synthesis of CBZ, as well as employing over 25 reactants across the synthetic routes. There also appears to be a lack of mention of the number of carcinogenic impurities of the drug. This review article aims to summarize the potential for the presence of potential carcinogenic impurities and its carcinogenicity in the drug of CBZ. Which can arise from the various reactants involved in the manufacturing process of the drug and their individual role in imparting carcinogenicity to the final formulation.