Email this article Development of an Industrial Reference Sample for the Specific Activity of Erythropoietin
- Authors: Yakovlev A.K.1, Volkova R.A.1, Simutenko L.V.1, Postnova E.L.1, Batuashvili T.A.1, Voropaev A.A.1, Alpatova N.A.1, Tomilin V.A.1, Mytsa E.D.1, Bondarev V.P.1, Merkulov V.A.1
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Affiliations:
- Scientific Center for Expert Assessment of Medicines, Ministry of Health of the Russian Federation
- Issue: Vol 52, No 1 (2018)
- Pages: 90-94
- Section: Article
- URL: https://journals.rcsi.science/0091-150X/article/view/245005
- DOI: https://doi.org/10.1007/s11094-018-1770-0
- ID: 245005
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Abstract
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.
About the authors
A. K. Yakovlev
Scientific Center for Expert Assessment of Medicines, Ministry of Health of the Russian Federation
Author for correspondence.
Email: YAK.Aleksey@gmail.com
Russian Federation, Building 2, 8 Petrovskii Boulevard, Moscow, 127051
R. A. Volkova
Scientific Center for Expert Assessment of Medicines, Ministry of Health of the Russian Federation
Email: YAK.Aleksey@gmail.com
Russian Federation, Building 2, 8 Petrovskii Boulevard, Moscow, 127051
L. V. Simutenko
Scientific Center for Expert Assessment of Medicines, Ministry of Health of the Russian Federation
Email: YAK.Aleksey@gmail.com
Russian Federation, Building 2, 8 Petrovskii Boulevard, Moscow, 127051
E. L. Postnova
Scientific Center for Expert Assessment of Medicines, Ministry of Health of the Russian Federation
Email: YAK.Aleksey@gmail.com
Russian Federation, Building 2, 8 Petrovskii Boulevard, Moscow, 127051
T. A. Batuashvili
Scientific Center for Expert Assessment of Medicines, Ministry of Health of the Russian Federation
Email: YAK.Aleksey@gmail.com
Russian Federation, Building 2, 8 Petrovskii Boulevard, Moscow, 127051
A. A. Voropaev
Scientific Center for Expert Assessment of Medicines, Ministry of Health of the Russian Federation
Email: YAK.Aleksey@gmail.com
Russian Federation, Building 2, 8 Petrovskii Boulevard, Moscow, 127051
N. A. Alpatova
Scientific Center for Expert Assessment of Medicines, Ministry of Health of the Russian Federation
Email: YAK.Aleksey@gmail.com
Russian Federation, Building 2, 8 Petrovskii Boulevard, Moscow, 127051
V. A. Tomilin
Scientific Center for Expert Assessment of Medicines, Ministry of Health of the Russian Federation
Email: YAK.Aleksey@gmail.com
Russian Federation, Building 2, 8 Petrovskii Boulevard, Moscow, 127051
E. D. Mytsa
Scientific Center for Expert Assessment of Medicines, Ministry of Health of the Russian Federation
Email: YAK.Aleksey@gmail.com
Russian Federation, Building 2, 8 Petrovskii Boulevard, Moscow, 127051
V. P. Bondarev
Scientific Center for Expert Assessment of Medicines, Ministry of Health of the Russian Federation
Email: YAK.Aleksey@gmail.com
Russian Federation, Building 2, 8 Petrovskii Boulevard, Moscow, 127051
V. A. Merkulov
Scientific Center for Expert Assessment of Medicines, Ministry of Health of the Russian Federation
Email: YAK.Aleksey@gmail.com
Russian Federation, Building 2, 8 Petrovskii Boulevard, Moscow, 127051
