Mini Review Article: Advanced Techniques in Impurity Profiling and Analysis of Pharmaceuticals

Abstract

Rigorous impurity profiling is crucial to maintaining the safety and efficacy of pharmaceuticals, as even trace levels of impurities can impact drug quality. This review explores the systematic classification, identification, and quantification of impurities in drug substances. It emphasizes the use of advanced analytical methodologies, including both UV-based multicomponent analysis and cutting-edge techniques for identifying elemental and non-elemental impurities. Notably, sophisticated instrumentation such as Inductively Coupled Plasma Mass Spectroscopy (ICP-MS), Inductively Coupled Plasma Optical Emission Spectroscopy (ICP-OES), Atomic Absorption Spectroscopy (AAS), Laser-Induced Breakdown Spectroscopy (LIBS), Energy-Dispersive X-ray Fluorescence (ED-XRF), Neutron Activation Analysis (NAA), Glow Discharge Mass Spectrometry (GD-MS), and Thermal Ionization Mass Spectrometry (TIMS) are employed to accurately measure impurities at ultra-trace levels. The necessity of stringent impurity testing is highlighted by recent case studies involving drug recalls, including the withdrawal of valsartan and the recall of metformin due to the detection of carcinogenic impurities. Such incidents highlight the potential risks of inadequate impurity monitoring. This review aims to provide a holistic perspective on impurity profiling by integrating various analytical methodologies, ensuring a more thorough and reliable approach to pharmaceutical quality control. By uniting these advanced techniques, the review outlines a proactive framework that supports regulatory compliance and fosters drug safety, ultimately enhancing public health outcomes.