From 1 January 2018, the European Pharmacopeia (EP) and the United States Pharmacopeia (USP) have replaced the old methods for testing of heavy metals (USP <231> and Ph.Eur. 2.4.8) in raw materials with a new harmonised guideline “ICH Q3D”. Drug product manufacturers are responsible for providing a risk-based assessment of the elemental impurities, justifying that the contents for each of the 24 elements are below the exposure limit as described in ICH Q3D. Rie Romme Rasmussen from Eurofins explains that the elemental impurity level and variability must be established by validated analytical methods specific for each matrix to avoid biased results.

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