Genotoxic impurities in Famotidine according to Regulatory Perspective
Keywords:
Genotoxic impurities, Famotidine, NDMA, ICH M7, Regulatory guidelines, Nitrosamines, Analytical methods, LC-MS/MSAbstract
Ensuring patient safety and therapeutic efficacy is the cornerstone of pharmaceutical development. Genotoxic impurities (GTIs) substances capable of causing DNA damage pose serious safety concerns even at trace levels in active pharmaceutical ingredients (APIs). Famotidine, a histamine H₂-receptor antagonist used for peptic ulcer and gastroesophageal reflux disease, has been under scrutiny for potential nitrosamine impurities such as N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA). This study investigates genotoxic impurities in Famotidine according to current international regulatory guidelines, focusing on the analytical detection, classification, and control strategies as per ICH M7 and FDA frameworks. Using LC-MS/MS and GC-MS techniques, trace-level quantification of NDMA was achieved within sub-ppm limits. The paper highlights the significance of adopting stringent analytical protocols and process optimization to minimize GTI formation and ensure pharmaceutical safety.
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