ICP-MS And ICP-OES: Tools For Elemental Impurity Analysis

By Julia Spraul and Alyssa McBurney

Elemental impurity testing is a critical regulatory requirement to ensure the safety of drug products for patients. It is essential to evaluate the risk of elemental impurities from all potential sources during the manufacturing process, including process equipment, water, packaging, raw materials, drug substances, and the final product. With the phase-out of heavy metals colorimetric testing, updated regulatory guidelines from USP, ICH, EP, and JP now mandate the use of advanced techniques like ICP-MS or ICP-OES for elemental impurity testing. These methods have significantly improved the speed and accuracy of detecting harmful metals, ensuring drug products meet safety standards.

In addition to routine elemental impurity testing, Alcami utilizes both ICP-MS and ICP-OES for a variety of applications, including identifying unknown contaminants and supporting recent updates to monographs. Assay methods adhere to USP <730> Plasma Spectroscopy guidelines to ensure accuracy, precision, and repeatability. For rapid identification of unknowns, Alcami also employs non-validated semi-quantitative or fully quantitative screening methods, providing quick insights into elemental concentrations for investigational and decision-making purposes during manufacturing.