Application Brief

Meeting the new ICH and USP regulation for elemental impurities in pharmaceutical products using the SPECTRO ARCOS with axial plasma observation

Testing pharmaceutical products for the presence of heavy metals – such as arsenic, cadmium, lead, and mercury – has long been a priority for drugmakers. Recently, global regulators have codified modern methods and guidelines describing elemental impurity limits; they’ve also set analytical procedures for their determination.

This report outlines relevant modern methods and guidelines issued from June 2016 through January 2018 for testing drug products. It covers regulations from the United States Pharmacopeia (USP), as well as from the International Council on Harmonization (ICH) under the European Medicines Agency.

It also describes analytical procedures – including sample preparation, detection methods, and validation – for measuring elemental impurities in pharmaceuticals. The report demonstrates the use of the SPECTRO ARCOS ICP-OES spectrometer in meeting the requirements of <232> USP and ICH Q3D for analyzing pharmaceutical products with low daily doses.

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