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The Use of EDX Fluorescence Spectrometry for Pharmaceutical Elemental Impurity Analysis Based on USP<735>

New guidelines governing the analysis of elemental impurities in pharmaceuticals are being implemented. Toxic heavy metals and residual metal catalysts may exist in the raw materials of Active Pharmaceutical Ingredients (APIs) or be added during the manufacturing process. These impurities may be a risk to human health.

This white paper demonstrates that X-ray Fluorescence (XRF) is capable of performing elemental impurity analysis of the above 12 elements in various pharmaceutical materials, such as Cellulose, Talc and a Mixture of Cellulose, Talc and TiO2, by the calibration curve method using water solution standard samples, and verifying the qualification of USP <735>.