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Preface

Since the advent of the first book specifically focused on genotoxic (mutagenic) impurities that I authored and was released in 2010, a considerable amount of progress has been made in terms of management of such impurities. Indeed many of the concepts defined for the first time within the book have ultimately become enshrined in standard practice relating to mutagenic impurities. These include how to conduct a risk assessment, the use of SAR evaluation tools, compound‐specific limits, and the use of purge factors to assess carryover risk, to name a few. Indeed most if not all were ultimately captured within ICH M7, which was formalized in 2014.

As a result of this and continued advancement of the science pertaining to many of these and other concepts, it seemed timely to seek to update the book. Little did I or others foresee at the point where this was proposed the dramatic impact of N‐nitrosamines. By necessity, the book seeks to address not only the changes in general around management of mutagenic impurities, it also seeks to outline a holistic approach to management and control of N‐nitrosamines, covering all aspects of their management from a safety and quality perspective. As well as this new chapter has been added specifically seeking to examine side reactions that can result in mutagenic impurities, dramatically expanding on the work in the first book that was focused simply on sulfonate esters.