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Current Requirements for Assessment of Elemental Impurities (Heavy Metals) in Medicines

  • STRUCTURE OF CHEMICAL COMPOUNDS, METHODS OF ANALYSIS AND PROCESS CONTROL
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Pharmaceutical Chemistry Journal Aims and scope

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.

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Authors and Affiliations

  1. Scientific Center for Expert Assessment of Medicines, Ministry of Health of the Russian Federation, Building 2, 8 Petrovskii Boulevard, 127051, Moscow, Russia

    E. L. Kovaleva, A. I. Belanova, L. I. Panova & A. A. Zakharchenko

Authors
  1. E. L. Kovaleva
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  2. A. I. Belanova
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  3. L. I. Panova
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  4. A. A. Zakharchenko
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Additional information

Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 52, No. 1, pp. 54 – 59, January, 2018.

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Kovaleva, E.L., Belanova, A.I., Panova, L.I. et al. Current Requirements for Assessment of Elemental Impurities (Heavy Metals) in Medicines. Pharm Chem J 52, 84–89 (2018). https://doi.org/10.1007/s11094-018-1769-6

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  • DOI: https://doi.org/10.1007/s11094-018-1769-6

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