The presence of elemental impurities in pharmaceutical products has garnered significant attention due to their potential toxicological effects and the necessity for global harmonization of control strategies. This review presents a comprehensive analysis of the sources, detection techniques, regulatory developments, and control mechanisms associated with elemental impurities in pharmaceutical substances and formulations. With the implementation of guidelines such as ICH Q3D, USP 232233, and corresponding EMA directives, the pharmaceutical industry has been compelled to adopt advanced analytical techniques like ICP-MS, ICPOES, and XRF. This article examines 200 peer-reviewed references spanning 2020–2025, addressing the intricacies of sample preparation, method validation, application of quality by design (QbD), and the challenges of ensuring compliance across varied dosage forms, oral, parenteral, herbal, pediatric, and complex biologics. It also presents real-world case studies and comparative evaluations of impurity levels across different global markets. In addition, emerging strategies like green chemistry integration, portable analytical devices, and digital QMS platforms are discussed. The review culminates in expert recommendations to minimize patient exposure, enhance regulatory compliance, and promote environmental sustainability. This exhaustive review aims to act as a critical resource for researchers, regulatory professionals, and quality analysts navigating the evolving landscape of elemental impurity assessment.
Kumar et al. (Mon,) studied this question.
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