Mutagenic Impurities

Strategies for Identification and Control

Andrew Teasdale

• Publisher: Wiley
• Year: 2022
• Print ISBN:
  9781119551218
• eBook ISBN:
  9781119551256
• Edition: 1
• Topic: Medicina
• Subtopic: Farmacologia

Learn to implement effective control measures for mutagenic impurities in pharmaceutical development 

In Mutagenic Impurities: Strategies for Identification and Control, 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. 

The 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. 

The 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. 

Readers will also benefit from the inclusion of: 

• 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 

Perfect for chemists, analysts, and regulatory professionals, Mutagenic Impurities: Strategies for Identification and Control 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. 

Table of contents

• Cover
• Table of Contents
• Title Page
• Copyright Page
• List of Contributors
• Preface
• Section 1: The Development of Regulatory Guidelines for Mutagenic/Genotoxic Impurities – Overall Process
• Section 2: In Silico Assessment of Mutagenicity
• Section 3: Toxicological Perspective on Mutagenic Impurities
• Section 4: Quality Perspective on Genotoxic Impurities
• Index
• End User License Agreement