In 2018, the United States Pharmacopeia (USP) in General Chapters <232> and <233> updated the list of elements and maximum permissible daily exposure (PDE) values of elemental impurities in drugs, pharmaceutical substances, and raw materials. The USP is now aligned with the International Council for Harmonization (ICH) Q3D (R2) Step 5, the latest version of which was adopted in 2022.
USP Chapter <232> specifies the list of elements and their maximum permissible daily exposure (PDE) values according to the modes of administration: oral, parenteral (intravenous injection) and inhalation drugs, whereas Chapter <233> details the sample preparation, analytical procedures, and quality control validation protocols for the analysis of elements specified in Chapter <232>. The (ICH) Q3D (R2) Step 5 guidelines apply to the same group of pharmaceutical products and drug substances with the addition of limits for elemental impurities delivered via the cutaneous and transcutaneous route.
This work focuses on the practical benefits of the NexION® 1100 ICP-MS for the determination of a group of toxicologically relevant elements in a large volume of parenteral (LVP) pharmaceutical products. It demonstrates that the NexION 1100 working in helium Collision mode is well suited for the analysis of pharmaceuticals following USP Chapters <232>/<233> harmonized with ICH Q3D.