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Pharmaceutical Chemistry Journal

, Volume 52, Issue 1, pp 90–94 | Cite as

Development of an Industrial Reference Sample for the Specific Activity of Erythropoietin

  • A. K. Yakovlev
  • R. A. Volkova
  • L. V. Simutenko
  • E. L. Postnova
  • T. A. Batuashvili
  • A. A. Voropaev
  • N. A. Alpatova
  • V. A. Tomilin
  • E. D. Mytsa
  • V. P. Bondarev
  • V. A. Merkulov
Article
  • 39 Downloads

On the basis of WHO recommendations and the principles developed for the standardization of erythropoietins we selected one epoetin alfa pharmaceutical substances included in the State Register of Medicines as a candidate reference sample. The results of the manufacturer’s monitoring of this pharmaceutical substance complied with the requirements of the normative documentation and additional verification of identity by capillary zone electrophoresis demonstrated the presence of eight isoforms, which corresponded to the requirements of the European Pharmacopeia. Conditions for the preparation of an industrial reference sample in lyophilized form were developed. The industrial reference sample was attested in interlaboratory tests and the value of the attested property - specific activity - was 2400 IU/ampule, with confidence limits of 94.5% to 105.8%. Studies of the stability of the industrial reference sample developed here gave a shelf life of five years at a storage temperature of -20°C, with potential to extend this on the basis of stability monitoring results.

Keywords

erythropoietin specific activity reference sample attested value significance interval 

References

  1. 1.
    State Register of Medicines [in Russian], [Online resource] URL: https: // grls.rosminzdrav.ru (Date accessed October 27, 2017).Google Scholar
  2. 2.
    D. H. Henry, N. V. Dahl, and M. A. Auerbach, Am. J. Hematol., 87(3), 308 – 310 (2012).CrossRefPubMedGoogle Scholar
  3. 3.
    N. A. Alpatova, L. A. Gaiderova, A. K. Yakovlev, et al., BIOprep. Profil. Diagnost. Lech., 17(1), 13 – 27 (2017).Google Scholar
  4. 4.
    Russian Federation Ministry of Health and the Medical Industry Decree No. 212, Moscow (1995).Google Scholar
  5. 5.
    V. P. Bondarev, I. V. Borisevich, R. A. Volkova, et al., Ved. Nauchn. Tsentra Ékspert. Sredstv Med. Prim., No. 2, 28 – 32 (2013).Google Scholar
  6. 6.
    WHO Expert Committee on biological standardization, 40th report, No 800, annex 4, 181 – 215 WHO, Geneva (1990).Google Scholar
  7. 7.
    A. K. Yakovlev, L. A. Gaiderova, N. A. Alpatova, et al., Stand. Obraztsy, 1, 8 – 20 (2016).Google Scholar
  8. 8.
    European Pharmacopoeia 9th Ed.; [Online resource], URL: http://online6.edqm.eu/ep901/# (Date accessed October 27, 2017).
  9. 9.
    State Pharmacopeia of the Russian Federation [in Russian], Moscow (2015) XIII ed., Vol. 2.Google Scholar
  10. 10.
    MUK 4.1 / 4.2.588-96 (1996).Google Scholar
  11. 11.
    State Pharmacopeia of the Russian Federation [in Russian], Moscow (2015), XIII ed., Vol. 1, pp. 638 – 657.Google Scholar
  12. 12.
    A. K. Yakovlev, N. A. Alpatova, E. L. Postnova, et al., Med. Immunol. Zh., 19, 77 – 78 (2017).Google Scholar
  13. 13.
    State Standard GOST 33215-2014. Standartinform, Moscow (2016).Google Scholar
  14. 14.
    State Standard GOST 33216-2014. Standartinform, Moscow (2016).Google Scholar
  15. 15.
    European Convention for the Protection of Vertebrate Animals used for experimental and other scientific purposes, Council of Europe, Strasbourg (1986).Google Scholar
  16. 16.
    C. Burns, R. Tiplady, and J. Hockley, WHO, Geneva (2012); [Online resource]. URL: http://apps.who.int/iris/bitstream/10665/96601/1/ WHO BS 2012.2195 eng.pdf (Date accessed 27.10.2017).
  17. 17.
    C. Burns, A. F. Bristow, A. Daas, et al., Pharmeuropa Bio, 246 – 253 (2015).Google Scholar
  18. 18.
    P. L. Storring and Das R. E. Gaines, J. Endocrinol., 134(3), 459-484 (1992).Google Scholar
  19. 19.
    P. L. Storring, R. J. Tiplady, Das R. E. Gaines, et al., J. Endocrinol., 150(3), 401 – 412 (1996).Google Scholar

Copyright information

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

Authors and Affiliations

  • A. K. Yakovlev
    • 1
  • R. A. Volkova
    • 1
  • L. V. Simutenko
    • 1
  • E. L. Postnova
    • 1
  • T. A. Batuashvili
    • 1
  • A. A. Voropaev
    • 1
  • N. A. Alpatova
    • 1
  • V. A. Tomilin
    • 1
  • E. D. Mytsa
    • 1
  • V. P. Bondarev
    • 1
  • V. A. Merkulov
    • 1
  1. 1.Scientific Center for Expert Assessment of Medicines, Ministry of Health of the Russian FederationMoscowRussia

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