This book examines genotoxic impurities and their impact on thepharmaceutical industry. Specific sections examine this fromboth a toxicological and analytical perspective. Within thesesections, the book defines appropriate strategies to both assessand ultimately control genotoxic impurities, thus aiding the readerto develop effective control measures. An opening section coversthe development of guidelines and the threshold of toxicologicalconcern (TTC) and is followed by a section on safetyaspects, including safety tests in vivo and vitro, and datainterpretation. The second section addresses the risk posed bygenotoxic impurities from outside sources and frommutagens within DNA. In the final section, the book dealswith the quality perspective of genotoxic impurities focused on twocritical aspects, the first being the analysis and the second howto practically evaluate the impurities.