Sensitivity issues or the presence of analytes with unidentifiable structure are typical problems during many E&L studies. Case studies and possible solutions are discussed:

- Reasons for presence of unknown compounds and insufficient sensitivity

- Optimization of the study design to reduce the risks

- How to use E&L data even if sensitivity is not sufficient

- Approaches for direct and indirect identification

- Leachable or matrix artefacts: Approaches to assess the origin of unknown compounds

Our expert is Dr Tino Otte, Head of Sales and Consulting, Intertek Reinach, who delivered this presentation during the 2nd Annual Extractables & Leachables for Pharma Summit.

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