Mutagenic Impurities


Strategies for Identification and Control

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<p><b>Learn to implement effective control measures for mutagenic impurities in pharmaceutical development&nbsp;</b></p> <p>In&nbsp;<i>Mutagenic Impurities: Strategies for Identification and Control</i>,&nbsp;distinguished chemist Andrew Teasdale delivers&nbsp;a thorough examination&nbsp;of mutagenic impurities and their impact on the pharmaceutical industry. The book incorporates the adoption of the ICH M7 guideline and focuses on mutagenic impurities from both a toxicological and analytical perspective.&nbsp;</p> <p>The editor has created a primary reference for any professional or student&nbsp;studying or working with mutagenic impurities and offers readers a definitive narrative of applicable guidelines and practical, tested solutions. It demonstrates the development of effective control measures, including chapters on&nbsp;the purge tool for risk assessment.&nbsp;</p> <p>The book incorporates a discussion of N-Nitrosamines which was arguably the largest&nbsp;mutagenic impurity&nbsp;issue ever faced by the pharmaceutical industry, resulting in the recall of Zantac and similar drugs&nbsp;resulting from N-Nitrosamine&nbsp;contamination.&nbsp;</p> <p>Readers will also benefit from the inclusion of:&nbsp;</p> <ul> <li>A thorough introduction to the development of regulatory guidelines for mutagenic and genotoxic impurities, including a historical perspective on the development of the EMEA guidelines and the ICH M7 guideline&nbsp;</li> <li>An exploration of in silico assessment of mutagenicity, including use of structure activity relationship evaluation as a tool in the evaluation of the genotoxic potential of impurities&nbsp;</li> <li>A discussion of&nbsp;a toxicological perspective on mutagenic impurities, including the assessment of mutagenicity and examining the mutagenic and carcinogenic potential of&nbsp;common synthetic reagents&nbsp;</li> </ul> <p>Perfect for&nbsp;chemists, analysts, and regulatory professionals,&nbsp;<i>Mutagenic Impurities: Strategies for Identification and Control</i>&nbsp;will also earn a place in the libraries of&nbsp;toxicologists and clinical safety scientists seeking a one-stop reference&nbsp;on the subject of mutagenic&nbsp;impurity identification and control.&nbsp;</p>