Journal of Pharmaceutical Analysis and Drug Research ISSN: 3108-0839 (Online)

Authors: Dr. Raghav Mehta, Dr. Priyanka Saxena

Abstract : Trace elements and elemental impurities are present in various pharmaceuticals, food supplements, and environmental matrices at extremely low concentrations. Despite their minimal presence, they can exert significant biological effects, both beneficial and toxic. Accurate detection and quantification of these elements are critical for ensuring human safety and complying with international regulatory standards. This paper provides a comprehensive overview of trace element and elemental impurity analysis, highlighting analytical methodologies, regulatory perspectives, current challenges, and future research scope. It emphasizes the importance of sensitive analytical tools such as ICP-MS, AAS, and XRF in monitoring elemental impurities, and discusses the practical considerations involved in sample preparation, data interpretation, and method validation.

Keywords: Trace elements, elemental impurities, ICP-MS, AAS, pharmaceutical analysis, regulatory compliance, toxicology, analytical methodologies.