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Pharmalytical Summit 2021 - Drug Manufacturing & QC 4. Quality control of API potency, excipient blend uniformity, and heavy metals impurities by non-destructive and direct analysis of intact pills by XRF

XRF analyses show comparable concentrations to ICP-MS for Class 1 and 2a heavy metals by ICH-Q3D (USP<232>). We will demonstrate quality control of API potency, excipient blend uniformity, heavy metals impurities and the advantages of this non-destructive quality control ready technique for final product testing. In addition, we will discuss the usefulness of XRF in control of manufacturing processes (i.e. blending, tableting, etc.).

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