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20 May 2021 • 

Latest Analytical Techniques in Extractable and Leachables

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May 2021

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In contrast to other impurities the control of extractable and leachables is not well defined yet. by USP and PQRI, but there is room for .. Read more interpretation. In general, comprehensive screening is applied, using gas- and liquid chromatography techniques hyphenated with mass spectrometry, to aim for complete coverage on E&L. 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. 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.

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