Email this article Current Requirements for Assessment of Elemental Impurities (Heavy Metals) in Medicines
- Authors: Kovaleva E.L.1, Belanova A.I.1, Panova L.I.1, Zakharchenko A.A.1
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Affiliations:
- Scientific Center for Expert Assessment of Medicines, Ministry of Health of the Russian Federation
- Issue: Vol 52, No 1 (2018)
- Pages: 84-89
- Section: Structure of Chemical Compounds, Methods of Analysis and Process Control
- URL: https://ogarev-online.ru/0091-150X/article/view/245002
- DOI: https://doi.org/10.1007/s11094-018-1769-6
- ID: 245002
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Abstract
One element of ensuring the quality and safety of medicines consists of normalizing and controlling elemental impurities (heavy metals). The sources and causes of the presence of elemental impurities (heavy metals) in medicines are discussed. Changes in approaches to assessment of elemental impurities in medicines in the State Pharmacopeia and leading non-Russian pharmacopeias are discussed. A risk-oriented approach to assessing elemental impurities used in international practice is presented.
About the authors
E. L. Kovaleva
Scientific Center for Expert Assessment of Medicines, Ministry of Health of the Russian Federation
Email: chem@folium.ru
Russian Federation, Building 2, 8 Petrovskii Boulevard, Moscow, 127051
A. I. Belanova
Scientific Center for Expert Assessment of Medicines, Ministry of Health of the Russian Federation
Email: chem@folium.ru
Russian Federation, Building 2, 8 Petrovskii Boulevard, Moscow, 127051
L. I. Panova
Scientific Center for Expert Assessment of Medicines, Ministry of Health of the Russian Federation
Email: chem@folium.ru
Russian Federation, Building 2, 8 Petrovskii Boulevard, Moscow, 127051
A. A. Zakharchenko
Scientific Center for Expert Assessment of Medicines, Ministry of Health of the Russian Federation
Email: chem@folium.ru
Russian Federation, Building 2, 8 Petrovskii Boulevard, Moscow, 127051
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