Learn how to implement efficient control measures for mutagenic impurities in pharmaceutical development. In his book Mutagenic Impurities: Strategies for Identification and Control, renowned chemist Andrew Teasdale provides a comprehensive analysis of mutagenic impurities and their impact on the pharmaceutical sector. The text is centered around the adoption of the ICH M7 guideline and delves into mutagenic impurities from both toxicological and analytical viewpoints. This publication serves as a valuable resource for professionals and students involved in the study or handling of mutagenic impurities, offering a detailed overview of relevant guidelines and proven solutions. It showcases the establishment of successful control measures, including a section on the purge tool for risk assessment. Additionally, the book addresses the issue of N-Nitrosamines, which posed a significant challenge to the pharmaceutical industry, leading to the withdrawal of Zantac and similar medications due to N-Nitrosamine contamination. Readers will find valuable information on the development of regulatory guidelines for mutagenic and genotoxic impurities, as well as insights into in silico assessment of mutagenicity and a toxicological perspective on mutagenic impurities. Mutagenic Impurities: Strategies for Identification and Control is a must-read for chemists, analysts, regulatory professionals, toxicologists, and clinical safety scientists seeking a comprehensive reference on the topic.

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