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Application note

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

This application note shows the capabilities of the Epsilon 4, a bench top energy dispersive X-ray fluorescence spectrometer (EDXRF) to analyze elemental impurities according to USP <232> and ICH Q3D, following USP <735> guidelines.

The introduction of USP <232> and ICHQ3D has required the pharmaceutical industry to re-evaluate how elemental impurity (heavy metal) analysis is performed. USP <735> and EP 2.2.37. enable the use of X-ray fluorescence spectrometry for this analysis.

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