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Pharmaceutical Chemistry Journal

, Volume 52, Issue 1, pp 84–89 | Cite as

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

  • E. L. Kovaleva
  • A. I. Belanova
  • L. I. Panova
  • A. A. Zakharchenko
STRUCTURE OF CHEMICAL COMPOUNDS, METHODS OF ANALYSIS AND PROCESS CONTROL
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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.

Keywords

medicines elemental impurities (heavy metals) risk-oriented approach to assessment of elementalimpurity contents maximum permitted daily exposure 

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2018

Authors and Affiliations

  • E. L. Kovaleva
    • 1
  • A. I. Belanova
    • 1
  • L. I. Panova
    • 1
  • A. A. Zakharchenko
    • 1
  1. 1.Scientific Center for Expert Assessment of Medicines, Ministry of Health of the Russian FederationMoscowRussia

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