Determination of Elemental Impurities in Pharmaceuticals

This technical report outlines the determination of trace elemental impurities in pharmaceutical substances and products using High-Resolution Inductively Coupled Plasma Optical Emission Spectroscopy (HR-ICP-OES). It discusses the compliance requirements established by the United States Pharmacopeia (USP) chapters <232> and <233>, as well as the International Conference on Harmonization (ICH) Q3D guidelines. The document details the challenges associated with analyzing a variety of sample types and the need for instrumentation capable of handling diverse matrices. It presents the capabilities of the PlasmaQuant 9100 Elite system, which offers high sensitivity and spectral resolution for accurate quantification of elemental impurities. The report also describes the classification of elemental impurities into three groups based on toxicity and the associated permitted daily exposure limits. Additionally, it emphasizes the importance of method validation as per USP guidelines to ensure the reliability of analytical results.