Nitrosamine impurity: Management of unwelcome guest in pharma market Patel Ajay I.1, Mandavia Anjali K.1,*, Vyas Amit J.1, Patel Ashok B.2 1Pharmaceutical Quality Assurance Department, B. K. Mody Government Pharmacy College, Rajkot, Gujarat, India 2Government Pharmacy College, Gandhinagar, Gujarat, India *Corresponding Author E-mail: anjali.mandavia1@gmail.com
Online Published on 23 January, 2024. Abstract Nitrosamine impurities have been detected in various pharmaceutical products in recent days. Various sartans, ranitidine, nizatidine and metformin have been recalled from the markets due to the high limit of nitrosamine impurities. When assessing the danger of human cancer, pharmaceutical products ability to regulate potentially mutagenic and carcinogenic contaminants is crucial. The risk of their mutagenic and carcinogenic potential has increased with the recent finding of nitrosamine impurities in various commercially available medications. Nitrosamine is the substance deemed to be a potential human carcinogen by the International Agency for Research on Cancer (IARC). Impurities in nitrosamines have been shown to be mutagenic and carcinogenic; even very low exposure levels to these impurities can cause cancer. These impurities may be created by a reagent, catalyst, solvent, or raw materials employed in the manufacturing process and end up in drug substances or drug products. Angiotensin II receptor blocker (ARB) medications with nitrosamine impurities have caused widespread health problems. Risk management of nitrosamine impurity is necessary to control the level of this impurity in drug substance, drug product and APIs. By using risk management tools like fishbone diagram which is used to identify and organize the possible sources of nitrosamines in medicines. For detection of nitrosamine impurity different countries develops their own analytical methods. Top Keywords N-nitrosamine impurity, Carcinogenic, Risk assessment, Interim limits, Analytical method. Top |