Elemental Impurities in Pharmaceutical Materials Analysis

This case study outlines a method for determining trace elemental impurities in pharmaceutical substances and products. It discusses the challenges posed by traditional testing methods and presents a solution using the PlasmaQuant MS, compliant with ICH Q3D and USP Chapters <232> and <233>. The document details the new standards for elemental impurities, their classification, and the validation protocols necessary for accurate analysis, ensuring compliance with updated regulatory requirements.