{"product_id":"mutagenic-impurities-strategies-for-identification-and-control-9781119551218","title":"Mutagenic Impurities: Strategies for Identification and Control","description":"\u003cp\u003e • Author(s): Andrew Teasdale\u003cbr\u003e • Publisher: Wiley\u003cbr\u003e • Publisher Imprint: Wiley\u003cbr\u003e • BISAC: Chemistry - Analytic\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003e\u003cb\u003eLearn to implement effective control measures for mutagenic impurities in pharmaceutical development \u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eIn \u003ci\u003eMutagenic Impurities: Strategies for Identification and Control\u003c\/i\u003e, distinguished chemist Andrew Teasdale delivers a thorough examination 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. \u003c\/p\u003e \u003cp\u003eThe editor has created a primary reference for any professional or student 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 the purge tool for risk assessment. \u003c\/p\u003e \u003cp\u003eThe book incorporates a discussion of N-Nitrosamines which was arguably the largest mutagenic impurity issue ever faced by the pharmaceutical industry, resulting in the recall of Zantac and similar drugs resulting from N-Nitrosamine contamination. \u003c\/p\u003e \u003cp\u003eReaders will also benefit from the inclusion of: \u003c\/p\u003e  *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  *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  *A discussion of a toxicological perspective on mutagenic impurities, including the assessment of mutagenicity and examining the mutagenic and carcinogenic potential of common synthetic reagents   \u003cp\u003ePerfect for chemists, analysts, and regulatory professionals, \u003ci\u003eMutagenic Impurities: Strategies for Identification and Control\u003c\/i\u003e will also earn a place in the libraries of toxicologists and clinical safety scientists seeking a one-stop reference on the subject of mutagenic impurity identification and control. \u003c\/p\u003e","brand":"Wiley","offers":[{"title":"Hardcover","offer_id":45203301990551,"sku":"9781119551218","price":15727.0,"currency_code":"INR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0666\/3471\/1191\/files\/9781119551218.webp?v=1769208507","url":"https:\/\/atlanticbooks.com\/products\/mutagenic-impurities-strategies-for-identification-and-control-9781119551218","provider":"Atlantic Books","version":"1.0","type":"link"}