E20: Concepts in Pharmaceutical Impurity Analysis

One-Day Course 
Date to be announced; 8:30am – 5:00pm

Dr. Bernard Olsen, Olsen Consulting
Dr. Steve Baertschi, Baertschi Consulting LLC

This one-day short course will focus on the main concepts within pharmaceutical impurity analysis and the role that reference standards play.

This course in pharmaceutical impurity analysis would benefit analytical chemists within Quality Control, Analytical R&D, and Quality Assurance departments within organizations producing pharmaceutical products.


  1. The Role of Reference Standards in Pharmaceutical Ana
  2. The Origin of Pharmaceutical Imp
  3. Practical Method Development and Considerations for Determining Impurities
  4. Relative Response Factors and Impurity Reference St
  5. The Chemistry of Drug Deg
  6. Forced Drug Degradation in Stability Indicating Method Development
    7. Analyzing Elemental Impurities in Pharmaceutical Products

Dr. Bernard Olsen, Fellow of the American Association of Pharmaceutical Scientists. Dr. Olsen has over 37 years of experience in drug development including 29 years as a Senior Research Fellow at Eli Lilly & Co. He has contributed to the development, commercialization, and support of over 25 pharmaceutical products including numerous developmental drugs. He has published and given invited lectures on a wide array of drug development and analytical topics including high performance liquid chromatography, method development and validation, impurity determination and control, genotoxic impurities, physical property characterization, drug counterfeiting, regulatory aspects of drug development, and quality control.

Dr. Steve Baertchi – Ph.D. Organic Chemistry, Vanderbilt University Fellow of the American Association of Pharmaceutical Scientists. Retiring from Lilly in 2015, Dr. Baertschi has more than 29 years of experience in the pharmaceutical industry with a demonstrated track record of innovation and problem-solving. Dr. Baertschi has organized and chaired numerous scientific conferences on stress testing, stability, photostability, and impurities, and has published extensively in these areas, including two editions of a book on pharmaceutical stress testing and drug degradation.