API Development: Risk Evaluation and Control of Genotoxic Impurities
Event Date: November 08, 2012 at 10:00 AM EST
Developing a successful synthesis and manufacturing process for a small-molecule active pharmaceutical ingredient (API) requires not only approaches to optimize product yield, purity, and process conditions, but also a full understanding of the regulatory issues to ensure product quality. When developing synthetic routes to APIs, the stages at which impurity generation occurs must be elucidated to identify and determine impurities, including genotoxic impurities, in order in control their formation during a synthesis. This 60-minute webcast will offer insight from leading industry experts on current regulatory guidelines, including an analysis of FDA’s recently issued guidance in June 2012 on genotoxic impurities, and the analytical and chemical approaches used to control and mitigate the risk of genotoxic impurities in small-molecule API development. The webcast will offer insight on:
  • Regulatory guidelines regarding genotoxic impurities
  • Analytical and chemical approaches
  • Risks of genotoxic impurities in small-molecule API development


Patricia Van Arnum

Executive Editor
Pharmaceutical Technology


Ponnaiah Ravi, PhD

Senior Vice-President of R&D
Neuland Laboratories Limited

Christopher M Cimarusti, PhD
Non-Executive Director
Neuland Laboratories Limited

Bo Shen, PhD
Principal Scientist, Analytical R&D Department, Amgen
Chair of the AAPS Pharmaceutical Trace Impurities Focus Group

Edward Delaney, PhD
Reaction Science Consulting

This is a FREE streaming audio Webcast and does not require a phone line. If you have any questions regarding this Webcast, please contact Sara Barschdorf, sbarschdorf@advanstar.com.

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