Elemental Impurities in Pharmaceutical Products – Analysis using an Energy-Dispersive X-ray Fluorescence Spectrometer

The analysis processes that are recommended in many pharmacopoeias for the determination of impurities can require complex sample preparation. They sometimes do not show very good reproducibility and have to be matched to the sample matrix. Energy-dispersive XRF conforms to the analysis processes described without the requirement of extensive sample preparation. Using optimized excitation and evaluation parameters, the technology provides detection limits that are sufficient for the analysis of most of the relevant elements. This application note demonstrates the analysis of elemental impurities in pharmaceutical products using an energy-dispersive x-ray fluorescence spectrometer.