Reference Materials for the Composition of Antimicrobial Substances

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.

1. Volkova R. A., Fadeikina O. V., Klimov V. I., Sakanyan E. I., Olefir Yu. V., Merkulov V. A. et al. Topical issues related to reference standards in the sphere of circulation of biological products. BIOpreparations. Prevention, Diagnosis, Treatment. 2016;16(4):229–236. (In Russ.).

2. Merkulov V. A., Sakanyan E. I., Klimov V. I., Shemeryankina T. B., Yashkir V. A., Barmin A. V. Modern approaches to development of reference substances for evaluation of the quality of pharmaceuticals. Pharmaceutical Chemistry Journal. 2015;49(11):54–56. (In Russ.). https://doi.org/10.30906/0023-1134-2015-49-11-54-56

3. Gurevich K. G., Urakov A. L., Rozit G. A., Klen E.H, Samorodov A. V., Khaliullin F. A. Synthesis and antiplatelet and anticoagulant activity of thietane-containing 2-(5-bromo-2,4-dihydro-3-oxo-1,2,4-triazolyl-4) acetate salts. Pharmaceutical Chemistry Journal. 2021;55(5):3–8. https://doi.org/10.30906/0023-1134-2021-55-5-3-8

4. Buravchenko G. I., Maslov D. A., Alam Md. S., Grammatikova N. E., Frolova S. G., Vatlin A. A. Synthesis and characterization of novel 2-acyl-3-trifluoromethylquinoxaline 1,4-dioxides as potential antimicrobial agents. Pharmaceuticals. 2022;15(2):155. https://doi.org/10.3390/ph15020155

5. Omelchuk O. A., Tevyashova A. N., Shchekotikhin A. E. Recent advances in antifungal Recent advances in antifungal drug discovery based on polyene macrolide antibiotics. Russian Chemical Reviews. 2018;87(12):1206. https://doi.org/10.1070/RCR4841

6. Solovieva S. E., Olsufyeva E. N., Preobrazhenskaya M. N. Chemical modification of antifungal polyene macrolide antibiotics. Russian Chemical Reviews. 2011;80(2):103–126. https://doi.org/10.1070/RC2011v080n02ABEH004145

7. Gokhberg L. M., Grebenyuk A. Yu. Top 20 frontiers of world science. In: Higher School of Economics. Available via. 2022. (In Russ.). https://issek.hse.ru/news/562631350.html?ysclid=l6by0ug657857283217 [Accessed: 10 August 2022].

8. Shchekotikhin A. E., Olsuf’eva E. N., Iankovskaia V. S. Antibiotics and related compounds. Moscow: Laboratoriia znanii; 2022. 511 p. (In Russ.).

9. Goncharuk V. V., Syroeshkin A. V., Smirnov A. N., Lesnikov E. V., Popov P. I., Uspenskaya E. V. et al. New laser methods for determining the authenticity and quality control of medicines. RUDN Journal of Medicine. 2006;2(34):90–95. (In Russ.). https://cyberleninka.ru/article/n/novye-lazernye-metody-opredeleniya-podlinnosti-i-kontrolya-kachestva-lekarstvennyh-sredstv?ysclid=l6c50cnw2o335279373

10. Gegechkori V. I., Shulga N. A., Shchepochkina O. I., Gorokhovets N. V., Levko A. A., Chadova N. N. et al. Procedure of matter identification of reference material for composition of azithromycin with use of spectral method. Measurement Standards. Reference Materials. 2021;17(3):21–34. (In Russ.). https://doi.org/10.20915/2687-0886-2021-17-3-21-34