Latest Analytical Techniques in Extractable and Leachables

20th May 2021 | 10:00 am EST | Dr. Tom van Wijk, Abbott Healthcare Products BV, Weesp, Principal Scientist, Analytical Science and Technology Team lead Pharmaceutical analysis |BOOK FREE SEAT FOR THIS WEBINAR

In contrast to other impurities the control of extractable and leachables is not well defined yet. Currently guidance is provided e.g. by USP and PQRI, but there is room for interpretation. New guidance (ICHQ3E) is being developed. In general, comprehensive screening is applied, using gas- and liquid chromatography techniques hyphenated with mass spectrometry, to aim for complete coverage on E&L. Although considered to be the state-of-the -art approach, in practice this approach is not as straightforward as it may seem. Many assumptions are made and for effective approach an E&L database is deemed necessary. Moreover, the strategy is completely opposite compared to the strategy applied for potential mutagenic impurities which is highly relying on a theoretical assessment (Risk based approach). The presentation will focus on the analytical technique selection, challenges of coverage of E&L in the current strategy and finally a perspective on E&L analysis.

Presented by Dr. Tom van Wijk,  Principal Scientist, Analytical Science and Technology Team lead Pharmaceutical Analysis Abbott Healthcare Products BV, Weesp,

Tom van Wijk is a principal Scientist with over 20 years of experience in pharmaceutical analysis. Working at former Solvay Pharmaceuticals in early and late phase chemical and pharmaceutical development and currently supporting established marketed products at Abbott Healthcare Products in the Analytical Science and Technology Department. Specialized in small molecule impurity profiling, mass spectrometry and method development for the active materials as well as the formulated products. One of his key interests is developing applications and strategies to control trace levels of toxic impurities in pharmaceutical products, i.e. potential mutagenic impurities (PMI) per ICHM7, elemental impurities per ICH Q3D and last but not least extractable and leachables. Received his PhD on the semi-targeted screening for alkylating components, allowing detecting components in this class of components without prior knowledge.

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