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Review Paper | Pharmaceutical Science | Volume 15 Issue 5, May 2026 | Pages: 917 - 920 | India
A Review on Elemental Impurity Risk Assessment in Pharmaceutical Analysis
Abstract: Elemental impurities represent a critical safety concern in pharmaceutical products due to their toxicological effects, even at trace levels. Regulatory bodies such as the International Council for Harmonisation (ICH), the United States Pharmacopeia (USP), and the European Medicines Agency (EMA) have established stringent guidelines (ICH Q3D, USP <232>, <233>) to ensure patient safety. This review consolidates current knowledge on elemental impurity risk assessment, highlighting sources of contamination, analytical methodologies (ICP-MS, ICP-OES, AAS), and risk evaluation strategies based on permitted daily exposure (PDE) values. Case studies on contamination in herbal medicines and injectables illustrate practical challenges. Future directions include automation, nanotechnology-based sensors, and AI-driven predictive impurity profiling.
Keywords: Elemental impurities, contamination, nanotechnology-based sensors
How to Cite?: Raavi Malliswari, "A Review on Elemental Impurity Risk Assessment in Pharmaceutical Analysis", Volume 15 Issue 5, May 2026, International Journal of Science and Research (IJSR), Pages: 917-920, https://www.ijsr.net/getabstract.php?paperid=SR26508150023, DOI: https://dx.dx.doi.org/10.21275/SR26508150023