Enviar artigo por via de e-mail Current Requirements for Assessment of Elemental Impurities (Heavy Metals) in Medicines
- Autores: Kovaleva E.L.1, Belanova A.I.1, Panova L.I.1, Zakharchenko A.A.1
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Afiliações:
- Scientific Center for Expert Assessment of Medicines, Ministry of Health of the Russian Federation
- Edição: Volume 52, Nº 1 (2018)
- Páginas: 84-89
- Seção: 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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Resumo
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.
Sobre autores
E. Kovaleva
Scientific Center for Expert Assessment of Medicines, Ministry of Health of the Russian Federation
Email: chem@folium.ru
Rússia, Building 2, 8 Petrovskii Boulevard, Moscow, 127051
A. Belanova
Scientific Center for Expert Assessment of Medicines, Ministry of Health of the Russian Federation
Email: chem@folium.ru
Rússia, Building 2, 8 Petrovskii Boulevard, Moscow, 127051
L. Panova
Scientific Center for Expert Assessment of Medicines, Ministry of Health of the Russian Federation
Email: chem@folium.ru
Rússia, Building 2, 8 Petrovskii Boulevard, Moscow, 127051
A. Zakharchenko
Scientific Center for Expert Assessment of Medicines, Ministry of Health of the Russian Federation
Email: chem@folium.ru
Rússia, Building 2, 8 Petrovskii Boulevard, Moscow, 127051
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