Review on the modern analytical advancements in impurities testing

<p>Impurities in active pharmaceutical ingredients (APIs) and pharmaceutical drug products (DPs) lead to broader antithetical effects related to drug safety, efficacy, and regulatory compliance. This review discusses organic, elemental, and inorganic impurities, and residual solvents and stresses their impact on the quality of APIs and pharmaceutical DPs regarding patient safety. It endorses immensely developed contemporary analytical techniques like High-performance Liquid Chromatography (HPLC), and Gas Chromatography (GC), for organic impurities and discusses their hyphenated Mass Spectrometry (MS) chromatographic methodologies. Atomic Absorption Spectroscopy (AAS), Inductively Coupled Plasma (ICP) hyphenated with MS, and Optical Emission Spectroscopy (OES) techniques are discussed for mainly improved sensitivity and accuracy in the detection and identification of elemental and inorganic impurities. High-Resolution Mass Spectrometry (HRMS), Supercritical Fluid Chromatography (SFC), and ICP-hyphenated techniques alongside automation are among the emerging technologies that are discussed concerning their impending potential to solve intricacies related to complex drug matrices, challenging regulatory requirements, and new impurity profiles. The review underlines the discussion on harmonized global regulations and affordable access to advanced analytical techniques so that wider adoption is facilitated in the pharmaceutical industry. Imminent prospects are Artificial Intelligence (AI) incorporation, Machine Learning (ML), and green analytical methodologies to overcome the present confinements and to cater to the growing demands of the progressive pharmaceutical sector. This in-depth analysis is intended to help pharmaceutical stakeholders embrace novel impurity management approaches resulting in significantly enhanced drug quality and better healthcare outcomes on a global scale.</p>