Tuesday, 24 May 2005 - 3:15 PM

This presentation is part of: Applications of LC-MS in Drug Discovery/Development

Identification of Impurities and Degradation Products in Pharmaceutical Development and Pharmaceutical Products Using LC-MS and LC-MS/MS

Jason X. Tang, Wyeth Research, Pearl River, NY

Identifying impurities and degradation products during the pharmaceutical development process and after market is important because of science and business interests and also because of regulatory requirements. The impurity and degradant profiles of a process or product provides us with a good understanding of that process or product. This allows us to improve processes, increase product yield at lower cost; extend product shelf life and protect process patents. All major analytical techniques such as HPLC-mass spectrometry (LC-MS) and HPLC-tandem mass spectrometry (LC-MS/MS), NMR, and IR have been used in the characterizations of drug impurities and degradation products. LC-MS and LC-MS/MS are often the techniques of choices for identifying low-level impurities and degradation products because of their high sensitivities and separation powers in addition to the rich structural information that MS/MS produces. The development of atmospheric pressure ionization, such as electrospray ionization technique, has made it possible not only to characterize a complicated mixture using LC-MS and LC-MS/MS but also to study non-covalently associated complexes in solution. ESI-MS technique is becoming a very powerful technique for identifying non-covalently associated impurities such as crystals or particulates found in liquid pharmaceutical products. We have been providing support for identifying impurities and degradation products during pharmaceutical development processes and in market pharmaceutical products. Examples of structural characterization of impurities and degradation products using MS based techniques, such as characterizations of impurities found in the manufacturing process and in liquid pharmaceutical products, will be presented and discussed.

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