Mutagenic Impurities

Condition: BRAND NEW ISBN: 9781119551218 Author(s): Andrew Teasdale Format: Hardcover Language: English Year: 2022 Publisher: John Wiley & Sons Inc Pages: 544

Description: Learn to implement effective control measures for mutagenic impurities in pharmaceutical developmentA‚  InA‚ Mutagenic Impurities: Strategies for Identification and Control,A‚ distinguished chemist Andrew Teasdale deliversA‚ a thorough examinationA‚ 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.A‚  The editor has created a primary reference for any professional or studentA‚ 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 onA‚ the purge tool for risk assessment.A‚  The book incorporates a discussion of N-Nitrosamines which was arguably the largestA‚ mutagenic impurityA‚ issue ever faced by the pharmaceutical industry, resulting in the recall of Zantac and similar drugsA‚ resulting from N-NitrosamineA‚ contamination.A‚  Readers will also benefit from the inclusion of:A‚  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 guidelineA‚ 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 impuritiesA‚ A discussion ofA‚ a toxicological perspective on mutagenic impurities, including the assessment of mutagenicity and examining the mutagenic and carcinogenic potential ofA‚ common synthetic reagentsA‚  Perfect forA‚ chemists, analysts, and regulatory professionals,A‚ Mutagenic Im