Commentary Open Access

Impurity Profiling in Pharmaceuticals: Strategies, Analytical Techniques, and Regulatory Perspectives

Abstract

Impurity profiling is a crucial aspect of pharmaceutical quality control and drug development, aimed at identifying, quantifying, and controlling impurities in drug substances and products. Impurities can arise from raw materials, synthetic processes, degradation, or storage conditions and may impact drug safety, efficacy, and stability. Regulatory agencies, including the International Council for Harmonisation (ICH), U.S. Food and Drug Administration (FDA), and European Medicines Agency (EMA), provide strict guidelines for impurity identification and control. Analytical techniques such as high-performance liquid chromatography (HPLC), gas chromatography (GC), liquid chromatography–mass spectrometry (LC-MS), and nuclear magnetic resonance (NMR) spectroscopy are extensively employed for impurity profiling. This article presents a comprehensive overview of impurity profiling, covering its principles, methodologies, applications, and significance in ensuring pharmaceutical quality and regulatory compliance.

Aarav K. Sharma