CONTROL OF ELEMENTAL IMPURITIES IN MEDICINAL PRODUCTS: APPROACHES, HARMONIZATION AND DEVELOPMENT DIRECTIONS OF THE WORLD PHARMACOPOEIAS
Annotatsiya
The control of elemental impurities (heavy metals) is an integral part of ensuring the quality and safety of medicinal products, and the international harmonization of its pharmacopoeial basis is a pressing task of modern pharmacy. The aim of the analysis was to comparatively examine the approaches of the leading world pharmacopoeias to the control of elemental impurities, to identify their points of convergence and divergence and their development directions, and to substantiate the possibilities of their use in developing the State Pharmacopoeia of the Republic of Uzbekistan. Materials and methods: the ICH Q3D(R1/R2) guideline, the documents of Ph. Eur. (5.20; 2.4.20), USP (⟨232⟩; ⟨233⟩), JP (2.66), the WHO International Pharmacopoeia, the EAEU Pharmacopoeia, the State Pharmacopoeia of Uzbekistan (2.4.8; 2.4.27; 5.20) and the PDG harmonized chapter “Elemental Impurities (G-07)”, together with peer-reviewed literature from 2017–2026 (PubMed, Scopus, Semantic Scholar), were studied using content analysis, comparative and systematic-analytical methods. Results: the pharmacopoeias were found to have converged around a single scientific core – ICH Q3D (24 elements, four classes, PDE system) – and to be transitioning consistently from the traditional non-specific “heavy metals” test to toxicologically based, element-specific and risk-based control with instrumental determination (ICP-MS/ICP-OES); a key milestone of this harmonization was the PDG harmonized chapter “Elemental Impurities (G-07)”, signed off on 19 June 2024 (regional editions in 2025–2026). The remaining differences relate not to principle but to the speed of implementation, the availability of the analytical method and to special matrices (herbal preparations, etc.). Conclusions: the identified directions are of practical importance for preparing the second edition of the State Pharmacopoeia, developing national texts on elemental impurities and preparing for accession to the PDG. Keywords: elemental impurities, heavy metals, ICH Q3D, permitted daily exposure (PDE), pharmacopoeial harmonization, PDG, “Elemental Impurities (G-07)”, ICP-MS, risk-based control.