Impact of new requirements on elemental impurities

Spectrochemical elemental analysis of pharmaceuticals and raw materials used for their production will be in the nearest future an obligatory part of quality and safety control for compliance with new standards announced by the International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH Q3D). The present paper surveys R&D articles and scientific papers devoted to determination of the elemental impurities by inductively coupled plasma optical emission spectrometry and mass spectrometry (ICP-OES and ICP-MS) in different pharmaceuticals products that have been published since 2000. In reference to recent changes described in the United States Pharmacopoeia (USP) general chapters <232> and <233>, different aspects of such measurements are presented, including appropriate sample preparation procedures, possible interferences and means of their avoidance, suitable calibration strategies and validation parameters that have to be assessed to prove reliability of the analytical results on the elemental impurities in pharmaceutical products.