IMPURITY PROFILING IN PHARMACEUTICALS: REGULATORY REQUIREMENTS AND ANALYTICAL APPROACHES
Poornima M
Associate Professor, Pharmaceuticals chemistry, College of pharmacy Sri Venkateswara University, Redhills, Tamil Nadu, India
Impurity profiling is a critical component of pharmaceutical quality assurance, ensuring the safety, efficacy, and regulatory compliance of drug substances and products. Impurities may arise from various sources, including synthetic processes, degradation during storage, or interactions with excipients, and can significantly impact the therapeutic performance and toxicity profile of pharmaceutical formulations. Regulatory authorities such as the International Council for Harmonisation (ICH), US Food and Drug Administration (FDA), and European Medicines Agency (EMA) have established stringent guidelines for the identification, qualification, and control of impurities, including ICH Q3A, Q3B, Q3C, Q3D, and M7 for genotoxic impurities. Advances in analytical technologies, particularly chromatographic and spectroscopic methods such as HPLC, GC, LC-MS/MS, and NMR, have enhanced the detection and characterization of impurities at trace levels. Additionally, the implementation of Quality by Design (QbD) and risk-based approaches has improved impurity control strategies throughout the drug development lifecycle. This review discusses the classification, sources, regulatory requirements, and analytical methodologies involved in impurity profiling, along with emerging challenges and future perspectives in pharmaceutical analysis
16 , 1 , 2026
32 - 35