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Monitoring Impurities in Pharmaceuticals
Sunday, November 11
8:30 am – 4:00 pm
Short Course
ACPE #073-999-07-502-L04
Monitoring impurities in pharmaceuticals is of major interest to scientists working in the pharmaceutical field. The concerns relate to determining how impurities are introduced into pharmaceuticals and the best way to identify and monitor them. The combination of chromatography and spectroscopy provides very desirable methods for characterizing impurities. However, at times it is necessary to isolate and characterize the impurities to confirm the structures deduced by the other methods or to utilize them as standards or to perform toxicity studies. The short course will cover all of these topics, including what constitutes an impurity, and how or when impurities should be profiled.
Moderator
Satinder Ahuja, Ph.D.
Ahuja Consulting, Inc.
Assuring Drugs Quality by Monitoring Impurities
Satinder Ahuja, Ph.D.
Ahuja Consulting, Inc.
Pharmaceutical Impurity Isolation and Identification in Early Development
Michael Coutant, Ph.D.
Pfizer, Inc.
Impurity Evaluations in Drug Products
Stephen Scypinski, Ph.D.
Bristol-Myers Squibb Company
Hyphenated Analytical Techniques
Daniel L. Norwood, Ph.D.
Boehringer Ingelheim Pharmaceuticals, Inc.
Using Quality by Design to Facilitate Establishment of Impurity Acceptance Criteria
Scott Furness, Ph.D.
U.S. Food and Drug Administration