Pharmaceutical Industry Practices on Genotoxic Impurities  book cover
1st Edition

Pharmaceutical Industry Practices on Genotoxic Impurities

Edited By

Heewon Lee

ISBN 9781439874202
Published August 29, 2014 by CRC Press
536 Pages 493 B/W Illustrations

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Book Description

A great deal of confusion and uncertainty over genotoxic impurity (GTI) identification, assessment, and control exists in the pharmaceutical industry today. Pharmaceutical Industry Practices on Genotoxic Impurities strives to facilitate scientific and systematic consensus on GTI management by presenting rationales, strategies, methods, interpretations, practices, and case studies from the pharmaceutical industry. Featuring the contributions of industry leaders from nine major pharmaceutical companies, this authoritative text:

  • Explores the safety, quality, and regulatory aspects of GTIs
  • Provides an overview of the latest FDA and EMEA guidelines
  • Explains the how and why of various GTI control tactics and practices
  • Describes genotoxicity evaluation, acceptable exposure calculation, and analytical methods for testing
  • Includes real-life examples of GTI control in drug substance and drug product development processes

Containing case studies from large and small pharmaceutical firms in multiple geographical regions, Pharmaceutical Industry Practices on Genotoxic Impurities supplies an overview of—and a current framework for—GTI control in the pharmaceutical industry, demonstrating how proper management of GTIs can occur with the appropriate guidance, a firm grasp of the practical implications, and effective information sharing between disciplines.

Table of Contents



List of Contributors

Overview of Regulatory Guidelines on Impurities and Genotoxic Impurities, Heewon Lee and Debie Hoivik

Structural Alerts for Genotoxicity and Carcinogenicity, Heewon Lee

Acceptable Exposure Calculations for Impurities and Selected Compounds from the Carcinogenic Potency Database, Heewon Lee

Genotoxic Impurities from Toxicology Perspectives Including Cancer Risk Assessment, In Silico, In Vitro/In Vivo Testings, and Regulatory Aspects, Esther Vock

In Silico/Computational Assessment for the Evaluation of Genotoxic Impurities, Alexander Amberg, Andreas Czich, and Véronique Thybaud

Preclinical Assessment of Genotoxic Impurities: An Overview of Current Regulatory Guidance, Available Assays, and Data Interpretation, Todd J. Page, Vincent L. Reynolds, and J. Barry Phelps

Purification of Lead Compounds for Early Toxicology Profiling such as Ames and Short-Term Nongood Laboratory Practice Toxicology Tests, Zheng Hua, Wesley W. Barnhart, and Kyung H. Gahm

Analysis of Genotoxic Impurities in Pharmaceuticals by Gas Chromatography–Mass Spectrometry, Jie Zheng and Adam P. Schellinger

Control of Chloroethane in Raw Materials and Drug Substances Using Headspace/Gas Chromatography Analysis, Johanna Ubben and Bing-Shiou Yang

Quantification of Genotoxic Impurities in Active Pharmaceutical Ingredients, Roy Helmy, Sophie Strickfuss, Mohammad Al-Sayah, Simon Hamilton, Xiaodong Bu, Claire Lee, Tiebang Wang, and Christopher Welch

Analytical Testing and Control for Genotoxic Impurities in Drug Substances, Jane Li and Larry Wigman

Approaches to Assess, Analyze, and Control Genotoxic Impurities in Drug Substance Development, Heewon Lee

Control and Analysis of Genotoxic Impurities in Drug Substance Development, Zhi Chen, Jianbing Zhang, Shan Xiao, Qin Ji, and Frances Liu

Salt Formation of Pharmaceutical Compounds and Associated Genotoxic Risks, Soojin Kim

Identification and Control of Genotoxic Degradation Products, Fenghe Qiu

Identification and Qualification of Genotoxic Impurities as Leachables in Drug Products, Douglas J. Ball, William P. Beierschmitt, Krista L. Dobo, and Cynthia J. Magee

Pharmaceutical Industry Survey on Genotoxic Impurities and Related Topics, William A. Yakush and Heewon Lee


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Heewon Lee is Senior Associate Director of the Chemical Development Department at Boehringer-Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, USA. She is also leader of the Analytical Research Group, an active participant in the Genotoxic Impurity Council, and a member of the Pharmaceutical IQ Consortium Working Group. She holds a BS and a MS from Seoul National University, South Korea, as well as a Ph.D from the University of Michigan, Ann Arbor, USA. Previously, she worked at ArQule, a biotechnology company located in Woburn, Massachusetts, USA. After ArQule, she joined the Medicinal Chemistry Department at Boehringer-Ingelheim before moving to her current position.