Published Paper Details:

Nitrosamine impurities have emerged as a significant safety concern in the pharmaceutical industry due to their potential mutagenic and carcinogenic properties. These compounds belong to the class of N-nitroso derivatives that may form during various stages of pharmaceutical manufacturing, including active pharmaceutical ingredient (API) synthesis, formulation, and storage. The detection of nitrosamine impurities such as N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) in several medicinal products has prompted extensive regulatory scrutiny and product recalls worldwide. Nitrosamines can originate from multiple sources, including contaminated raw materials, degradation reactions, solvent impurities, and interactions between drug substances and excipients. To ensure patient safety, regulatory authorities such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the International Council for Harmonisation (ICH) have issued guidelines for risk assessment, detection, and control of these impurities. Advanced analytical techniques, including gas chromatography-mass spectrometry (GC-MS), liquid chromatography-mass spectrometry (LC-MS/MS), and high-performance liquid chromatography (HPLC), are widely employed for the identification and quantification of nitrosamines at trace levels. This review discusses the chemical characteristics, formation mechanisms, potential sources, analytical detection methods, regulatory requirements, and mitigation strategies related to nitrosamine impurities in pharmaceutical products.