Regulatory Considerations of Pharmaceutical Impurities with Emphasis on Genotoxic Impurities

Abstract

Over the past decade, significant changes have occurred in the approach to drug impurity profiling, as reflected in pharmacopeial and regulatory standards. This review provides an in-depth exploration of impurity profiling, focusing on the regulatory requirements. It offers detailed insights into various impurities such as residual solvents, water impurities, elemental contaminants, and carcinogenic substances, with special attention to genotoxic impurities. To meet the required quality standard

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