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President\'s Message

Integrated Approaches for Impurity and Degradant Identification
Thursday, March 6, 2008
1:30 p.m., Room 262

Organizer:

Mike S Lee, Milestone Development Services

Speakers:

1:30     Case Studies of Impurity Analysis in Drug Products and Drug Substances by LC MS (n)   ARINDAM ROY, Covidien

1:50     Understanding the Use of Temperature Regulation to Optimize Mass Transfer in Fast Gradient Reversed Phase Liquid Chromatography  MARK HAYWARD, Lundbeck Research

2:10     Integrating Automated Data Analysis with Optimized LC-DAD-ELSD-CLND-MS  KENNETH C LEWIS, OpAns, Joseph D Simpkins

2:30     Ultra-Low Flow Rate Electrospray: Exploration of Equimolar Response, Limits and Applications  GARY A VALASKOVIC, New Objective Inc.

2:50     Recess

3:05     High Resolution LC/MS Methodologies for Structural Characterization of Impurities and Degradation Products in Drug Substances  BIRENDRA N PRAMANIK, Schering-Plough

3:25     A New Approach to Ion Sampling in LC/MS/MS: Going with the Flow from Theory to Practice  DRAGAN VUCKOVIC, Ionics Mass Spectrometry Group, Lisa Cousins

3:45     Application of DART and DESI Techniques for Direct Analysis of Impurities and Degradants  TODD GILLESPIE, Eli Lilly and Company

4:05     A Repository for Impurity and Degradant Analytical Characterization Data  RANDALL K JULIAN, Indigo BioSystems

Overview:

The combination of high performance liquid chromatography and mass spectrometry (LC/MS) has evolved as the premier tool for the identification of impurities.  Recent advances in high performance liquid chromatography (HPLC) and MS have resulted in unprecedented levels of analytical performance.  Sensitivity and selectivity has been increased significantly with the use of novel chromatography formats and high resolution mass spectrometers.  This session will highlight recent innovations that feature high resolution separations with chromatography and mass spectrometry techniques.  Industry leaders who have been responsible for these recent developments will be featured.