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![]() Integrated Approaches for Impurity and Degradant Identification
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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.
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