We were delighted to contribute to a new book on Mutagenic Impurities, edited by Andrew Teasdale – “Mutagenic Impurities: Strategies for Identification and Control”.1

The book incorporates a discussion on the ICH M7 guideline and covers the in silico assessment of mutagenicity, including the use of structure-activity relationship methodologies, to support the evaluation of impurities. The book also covers N-Nitrosamines, a critical mutagenic impurity issue facing the pharmaceutical industry today.

The book is organized into 4 sections:

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

We would like to congratulate Andrew on the completion of this impressive and valuable book on mutagenic impurities.


  1. https://www.wiley.com/en-ie/Mutagenic+Impurities:+Strategies+for+Identification+and+Control-p-9781119551218

Published by Glenn Myatt

Glenn J. Myatt is the co-founder of Leadscope and currently Senior Vice President, In Silico & Translational Science Solutions at Instem with over 25 years’ experience in computational chemistry/toxicology. He holds a Bachelor of Science degree in Computing, a Master of Science degree in Artificial Intelligence and a Ph.D. in Chemoinformatics. He has published 34 papers, 10 book chapters and three books.