Screen LibraryMutagenic impurities : strategies for identification and control /
"This book examines mutagenic impurities and their impact on the pharmaceutical industry, following the adoption of the ICH M7 guideline, while focusing on mutagenic impurities from both a toxicological and analytical perspective. The book serves as a primary reference point for anyone faced wi...
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| Group Author: | |
|---|---|
| Published: |
Wiley,
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| Publisher Address: | Hoboken, NJ : |
| Publication Dates: | 2022. |
| Literature type: | Book |
| Language: | English |
| Subjects: | |
| Summary: |
"This book examines mutagenic impurities and their impact on the pharmaceutical industry, following the adoption of the ICH M7 guideline, while focusing on mutagenic impurities from both a toxicological and analytical perspective. The book serves as a primary reference point for anyone faced with addressing the issue of mutagenic impurities, providing readers with a definitive narrative of the guidelines and actual practical solutions to allow them to develop effective control measures"-- |
| Carrier Form: | xxi, 522 pages : illustrations, forms ; 26 cm |
| Bibliography: | Includes bibliographical references and index. |
| ISBN: |
9781119551218 1119551218 |
| Index Number: | QH462 |
| CLC: | Q319 |
| Call Number: | Q319/M992-2 |
| Contents: | Historical perspective on the development of the EMEA Guideline and subsequent ICH M7 Guideline -- ICH M7 -assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk -- Control strategies for mutagenic impurities -- Use of structure-activity relationship (SAR) evaluation as a critical tool in the evaluation of the genotoxic potential of impurities -- Evolution of quantitative structure-activity relationships ((Q)SAR) for mutagenicity -- Toxicity testing to understand the mutagenicity of pharmaceutical impurities -- Compound- and class-specific limits for common impurities in pharmaceuticals -- Genotoxic threshold mechanisms and points of departure -- Mutagenic impurities -assessment of fate and control options -- N-nitrosamines -- Conditions potentially leading to the formation of mutagenic impurities -- Strategic approaches to the chromatographic analysis of mutagenic impurities -- Analysis of mutagenic impurities by nuclear magnetic resonance (NMR) spectroscopy -- Addressing the complex problem of degradation-derived mutagenic impurities in drug substances and products. |