Abstract
The present study aims to generalize the experience of creating state reference materials (GSOs) of active substances and determine their main characteristics, standardized both in the State Pharmacopoeia of the Russian Federation and in the regulatory documents of the measurement uniformity assurance system. In connection with the violation of supply chains, the acquisition and use of foreign reference active substances became quite problematic or even impossible. As a consequence of the current difficult situation with the insufficient nomenclature of GSOs, the domestic manufacturers and developers faced urgent problems in creating them. The development of antimicrobial reference active substances will solve urgent issues of strengthening the technological sovereignty of Russia, minimize the import dependence of the Russian economy, as well as ensure the targets of the Strategy for Scientific and Technological Development of the Russian Federation to be achieved. The conclusions of the study can be applied in creating GSOs to substitute imported reference materials or surpass their level.
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Notes
- 1.
Reference materials of active substances, manufactured in accordance with the requirements of United States Pharmacopoeia (USP), European Pharmacopoeia (EP), and British Pharmacopoeia (BP) by the National Institute of Biological Standards and Control (NIBSC) and national metrological institutes of other countries.
- 2.
Scroll vital and essential medicines for medical applications. Available via https://www.consultant.ru/document/cons_doc_LAW_335635/a80818c7d9593b31dbdbd0d3418aec02298bd57d6d/. Accessed 4 August 2022 (In Russ.).
- 3.
Federal Information Fund for Ensuring the Uniformity of Measurements. Available via FIF EUM. https://fgis.gost.ru/fundmetrology. Accessed 10 August 2022 (In Russ.).
- 4.
The work was performed within the framework of the “Bioanalitika” research and development work, an integral part of the “Komponent” research and development work, a state contract dated 06/16/2017, No. 120-93.
This work was carried out in order to ensure the comprehensive development of the metrological assurance in the field of bioanalytical measurements; creation of tools and methods for the metrological assurance of measurements in the field of bioanalytical measurements, including laboratory diagnostics; ensuring reliable measurement results obtained using measuring instruments by creating the reference materials of active substances; ensuring the reliability of measuring the composition (purity) of initial active substances used for the manufacture of medicinal products traceable in accordance with the legislation on the measurement uniformity assurance.
- 5.
FR.R1.31.2019.00005 Reference method for measuring the composition (purity) of the original pharmaceutical substances: Amphotericin B, Olivomycin A, Natamycin. Available via FIF EUM. https://fgis.gost.ru/fundmetrology/registry/8/items/834985. Accessed 10 August 2022 (In Russ.).
- 6.
GET 196-2015 State primary standard of units of mass (molar) fraction and mass (molar) concentration of components in liquid and solid substances and materials based on spectral methods: Custodian Institute All-Russian Research Institute for Optical and Physical Measurements. Available via FIF EUM. https://fgis.gost.ru/fundmetrology/registry/12/items/397882. Accessed 10 August 2022 (In Russ.).
- 7.
FIF OEI No. 54391-13 Non-automatic scales, Sartorius Weighing Technology GmbH, Germany. Available via FIF EUM. https://fgis.gost.ru/fundmetrology/registry/4/items/366830. Accessed 10 August 2022 (In Russ.).
- 8.
FIF OEI No. 36152-07 Automatic and mechanical single-channel dispensers, BIOHIT OYJ, Finland. Available via FIF EUM. https://fgis.gost.ru/fundmetrology/registry/4/items/345455. Accessed 10 August 2022 (In Russ.).
- 9.
FIF OEI No. 67389-17 Spectrophotometers, JASCO International Co., Ltd, Japan. Available via FIF EUM. https://fgis.gost.ru/fundmetrology/registry/4/items/381335. Accessed 10 August 2022 (In Russ.).
- 10.
FIF OEI No. 66036-16 Fourier transform infrared spectrometers, Thermo Fisher Scientific, USA. Available via FIF EUM. https://fgis.gost.ru/fundmetrology/registry/4/items/379856. Accessed 10 August 2022 (In Russ.).
- 11.
FIF OEI No. 47938-17 High-performance liquid chromatographs, LLC IH EkoNova, Russia. Available via FIF EUM. https://fgis.gost.ru/fundmetrology/registry/4/items/359326. Accessed 10 August 2022 (In Russ.).
- 12.
FIF OEI No. 15495-02 pH meters, Metrohm Ltd., Switzerland. Available via FIF EUM. https://fgis.gost.ru/fundmetrology/registry/4/items/313568. Accessed 10 August 2022 (In Russ.).
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Acknowledgements
The work was carried out with the support of the State Contract “Komponent” Research and Development work dated June 16, 2017 No. 120-93 and its integral part “Bioanalitiks” Research and Development work.
The authors express their gratitude to Professor L. K. Isaev and Dr. Sci. (Engineering) Professor A. Yu. Kuzin for their support and invaluable advice on the topic in question, to Dr. Sci. (Engineering) F. V. Bulygin for constant live participation in the formation of a scientifically grounded position of the authors, to Leading Researcher of the FSBI “VNIIMS” O. N. Melkova and Leading Researcher of the FSBSI “NIINA” Cand. Sci. (Chemistry) S. E. Solov’yova for the invaluable contribution to this work.
Author Contribution
Kulyabina E. V.—development of research concept, obtaining funding, development of methodology, supervision of research; Shchekotikhin A. E.—management of research work, provision of research materials; Tevyashova A. N.—conducting research work, curating data; Kulyabina T. V.—text verification and editing, validation, control; Morozova V. V.—draft writing, preparation and creation of visual materials.
Conflict of Interest
The article was prepared on the basis of a report presented at the V International Scientific Conference “Reference Materials in Measurement and Technology” (Yekaterinburg, September 13–16, 2022). The article was admitted for publication after the abstract was revised, the article was formalized, and the review procedure was carried out.
The version in the Russian language is published in the journal “Measurement Standards. Reference Materials” 2023;19(4):17–26. (In Russ.). https://doi.org/10.20915/2077-1177-2023-19-4-17-26.
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Kulyabina, E.V., Shchekotikhin, A.E., Tevyashova, A.N., Kulyabina, T.V., Morozova, V.V. (2024). Reference Materials for the Composition of Antimicrobial Substances. In: Sobina, E.P., et al. Reference Materials in Measurement and Technology . RMMT 2022. Springer, Cham. https://doi.org/10.1007/978-3-031-49200-6_3
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