Pharmaceutical Impurities and Their Regulatory Aspects with a Special Focus on Genotoxic Impurities
Abstract
Drug impurity profile studies have changed significantly during the past ten years, as demonstrated by pharmacopeia and regulatory standards. This review article aims to give viewers a thorough understanding of the numerous facts of impurity profiling in relation to regulatory criteria. Comprehensive information on residual solvents, water impurities, elemental impurities, carcinogenicity and an overview of the most critical components of genotoxic contaminants. To ensure the drug products fulfill the minimal acceptable quality standards and a number of pharmacopoeias have created monographs. ICH, EMEA, USFDA and European Pharmacopeia recommendations are just a few of the regulatory bodies that offer rules to reduce the amount of contaminants in medications. In order to prevent impurities, industry, research and development sectors widely employ different spectrum analyses including HPLC, LC/MS and GC/MS. It involves the recall of medications because of these contaminants. The significance of understanding genotoxic impurities as a crucial element of the impurity profile in medications is emphasized in this abstract.
Keywords: Impurity, Genotoxic, Mutagenic, Carcinogenic, Regulatory guidelines
