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Modern Approaches to the Development of Reference Standards for Quality Assessment of Drug Substances

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Pharmaceutical Chemistry Journal Aims and scope

Reference standards, including pharmacopoeial reference standards, are widely used for quality assessment of drug substances. Leading global pharmacopoeias contain monographs regulating the requirements for the classification, attestation, and use of reference standards. The drug standardization system in the Russian Federation, which includes drug substances, requires revision for the creation and attestation of national reference standards, including pharmacopoeial ones.

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References

  1. Federal Law No. 429, On Amendments to FL “On the Circulation of Medicines” (2014).

  2. Federal Law No. 61, On the Circulation of Medicines (2010).

  3. Russian Federation State Pharmacopoeia, XIIth Ed., Part 1, Scientific Center for Expertise of Medical Products, Moscow (2008).

  4. European Pharmacopoeia, 8th Ed., European Directorate for the Quality of Medicines and Healthcare; http://online.edqm.eu/entry.htm

  5. United States Pharmacopoeia, 37th Ed., United States Pharmacopeial Convenction; http://www.uspnf.com/uspnf/login

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Authors and Affiliations

  1. Scientific Center for Expertise of Medical Products, Ministry of Public Health of the Russian Federation, Moscow, 127051, Russia

    V. A. Merkulov, E. I. Sakanyan, V. I. Klimov, T. B. Shemeryankina, V. A. Yashkir & A. V. Barmin

Authors
  1. V. A. Merkulov
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  2. E. I. Sakanyan
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  3. V. I. Klimov
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  4. T. B. Shemeryankina
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  5. V. A. Yashkir
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  6. A. V. Barmin
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Additional information

Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 49, No. 11, pp. 54 – 56, November, 2015.

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Merkulov, V.A., Sakanyan, E.I., Klimov, V.I. et al. Modern Approaches to the Development of Reference Standards for Quality Assessment of Drug Substances. Pharm Chem J 49, 776–778 (2016). https://doi.org/10.1007/s11094-016-1369-2

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  • DOI: https://doi.org/10.1007/s11094-016-1369-2

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