Abstract
Standardization is essential in the process of developing novel drugs, as well as updating approaches to the quality control of medicines in circulation. Establishing methods of quality control using reliable, accurate, and sensitive physicochemical methods is a crucial issue in standardization. This, in turn, requires the development of reliable reference materials (RMs). This article considers the development of methods for determining the structure of azithromycin, which is important for ensuring the purity of RMs and selecting an adequate technique of quantification according to the current regulatory documents, as well as the State Pharmacopoeia of the Russian Federation (XIV Edition).
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Notes
- 1.
RF, General Pharmaceutical Norms and Regulations GPNR.1.2.1.2.0007.15 “Nuclear magnetic resonance spectroscopy”.
- 2.
RF, GPNR.1.2.1.1.0008.15 “Mass spectrometry”, GPNR.1.2.1.2.0005.15 “High-performance liquid chromatography”.
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Acknowledgements
The authors express their gratitude to the First Deputy Director Sergey Viktorovich Polyakov, researchers of the Laboratory for Analytical Research Methods of the State Institute of Drugs and Good Practices, as well as employees of the National Center for Reference Materials, LLC.
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V.I. Gegechkori and O. Yu. Schepochkina: discussion, analysis, and processing of experimental data; text preparation.
N.A. Shulga: analysis of literature data.
N.V. Gorokhovets: collection and analysis of experimental data, text preparation.
V.N. Shestakov and A.A. Levko: research supervision.
N.N. Chadova: text preparation.
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The article was prepared on the basis of a report presented at the IV International Scientific Conference “Reference Materials in Measurement and Technology” (St. Petersburg, December 1–3, 2020). 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” 2021;17(3):21–34. https://doi.org/10.20915/2687-0886-2021-17-3-21-34.
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Gegechkori, V.I. et al. (2022). Identification of Reference Materials of Azithromycin Composition Using Spectral Methods. In: Medvedevskikh, S.V., Sobina, E.P., Kremleva, O.N., Okrepilov, M.V. (eds) Reference Materials in Measurement and Technology . RMMT 2020. Springer, Cham. https://doi.org/10.1007/978-3-031-06285-8_4
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