Non-destructive elemental analysis of impurities in pharmaceuticals according to ICH Q3D and USP <232>

The data presented in this application note clearly demonstrate that the Epsilon 4 EDXRF spectrometer can measure elemental impurities at the levels required by ICH Q3D and USP <232> using only 100 mg of sample. The EDXRF data compares favorably with ICP data. 

The repeatability results illustrate the stability and robustness of the Epsilon 4. The combination of excellent detector resolution, high sensitivity and powerful software deconvolution models contribute to the accuracy and precision of the results. The non-destructive nature of the method makes it possible to measure the samples subsequently by other analytical techniques, if required.


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