Certified Reference Material for Quantitative Evaluation of Carbohydrate Stabilizers by Ion Exchange HPLC
https://doi.org/10.33647/2074-5982-21-1-26-33
Abstract
Quantitative determination of excipients is a pharmacopoeial requirement for assessing the quality of biological medicinal products. For determination of carbohydrate stabilizers (sorbitol, mannitol, trehalose, glucose, lactose, sucrose, and maltose), the Scientific Center for Expert Evaluation of Medical Products of the Ministry of Health of the Russian Federations prescribes the method of anionic exchange HPLC with pulse amperometric detection. Routine application of this method requires a reference material of in tralaboratory analytical control, since the suitability of chromatographic systems must be checked prior to use of all chromatographic methods for quality control of pharmaceutical substances and medicinal prod ucts. In addition, certified reference materials permit interlaboratory comparison of test results. In this study, we set out to develop the composition and a release form of a certified reference material for stability con trol of determination of carbohydrate stabilizers. The range of the resolution factor between the peak pairs of sorbitol/mannitol and mannitol/trehalose was used as a certified characteristic, being1.8–2.4 and 2.1–2.9, respectively. For other peak pairs (trehalose/glucose, glucose/lactose, lactose/sucrose, and sucrose/maltose), a semi-quantitative certified characteristic was assigned, i.e., a resolution factor of at least 3.0.
Supporting agencies: The study was carried out as part of a publicly funded research project No. 056-00026-24-01 and was supported by the Scientific Centre for Expert Evaluation of Medicinal Products (R&D public accounting No.124022200103-5).
About the Authors
A. S. Minero
Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health Сare of Russia
Russian Federation
Russian Federation
Anastasia S. Minero
127051, Moscow, Petrovsky Boulevard, 8, Build. 2
O. B. Rounova
Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health Сare of Russia
Russian Federation
Russian Federation
Olga B. Rounova, Cand. Sci. (Chem.)
127051, Moscow, Petrovsky Boulevard, 8, Build. 2
O. V. Fadeikina
Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health Сare of Russia
Russian Federation
Russian Federation
Olga V. Fadeikina, Cand. Sci. (Biol.)
127051, Moscow, Petrovsky Boulevard, 8, Build. 2
R. A. Volkova
Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health Сare of Russia
Russian Federation
Russian Federation
Rauza A. Volkova, Dr. Sci. (Biol.)
127051, Moscow, Petrovsky Boulevard, 8, Build. 2
O. B. Ustinnikova
Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health Сare of Russia
Russian Federation
Russian Federation
Olga B. Ustinnikova, Cand. Sci. (Biol.)
127051, Moscow, Petrovsky Boulevard, 8, Build. 2
References
1. Volkova R.A. Fadeikina O.V., Ustinnikova O.B., Sarkisyan K.A., Movsesyants A.A., Merkulov V.A., Kosenko V.V. Trebovaniya k materi alam razdela po standartnym obrazcam, predstavly aemym v dos'e na biologicheskie lekarstvennye sredstva [Requirements for the information on ref erence standards submitted in the dossier for biolog icals]. Biopreparaty. Profilaktika, diagnostika, leche nie [Biological Products. Prevention, Diagnosis, Treatment]. 2024;24(1):7–20. (In Russian). DOI: 10.30895/2221-996X-2024-24-1-7-20.
2. Minero A.S., Rouno va O.B., Korotkov M.G., Ustinnikova O.B. Razrabotka metodiki ionoobmennoj VEZHKH dlya kolichest vennogo opredeleniya stabilizatorov uglevodnoj prirody v biologicheskih lekarstvennyh preparatah [Development of an ion-exchange HPLC technique for the quantitative determination of carbohydrate sta bilizers in biological medicinal products]. Chemical and Pharmaceutical Journal. 2023;57(4):59–64. (In Russian). DOI: 10.30906/0023-1134-2023-57-4-59-64.
3. Minero A.S., Rounova O.B., Korotkov M.G., Ustinnikova O.B. Opredelenie stabi lizatorov uglevodnoj prirody v biologicheski aktivnyh preparatah [Determination of carbohydrate stabilizers in biologically active preparations]. Patent of FGBU “NCESMP” of Minzdrav Rossii. RU 2816030. MPK G01N 30/06 (2006.01), G01N 30/64 (2006.01), G01N 30/34 (2006.01). Application RU2023118379 A. Date of submission 12.07.2023. Date of publication 25.03.2024. (In Russian).
4. Fadeikina O.V., Volkova R.A. Razrabotka poryadka attestacii standartnyh obrazcov biologicheskih lekarst vennyh sredstv [Elaboration of cetrtification procedures for reference standards of biological drugs]. Chemical and Pharmaceutical Journal. 2017;51(8):44–50. (In Russian). DOI: 10.30906/0023-1134-2017-51-8-44-50.
5. Bjelosevic M., Zvonar Pobirk A., Planinsek O., Ahlin Grabnar P. Excipients in freeze-dried bio pharmaceuticals: Contributions toward formulation stability and lyophilisation cycle optimization. Int. J. of Pharmaceutics. 2020;76:1–12. DOI: 10.1016/j.ijpharm.2020.119029.
6. Center for Drug Evaluation and Research, U.S. Food and Drug Administration. Reviewer Guidance, Validation of Chromatographic Methods; FDA, Rockville, MD; 1994.
7. https://eec.eaeunion.org/upload/medialibrary/bd2/Farmakopeya-2020-t1_1.pdf
8. https://grls.rosminzdrav.ru/grls.aspx
9. https://pharmacopoeia.regmed.ru/pharmacopoeia/izdanie-15/1/1-2/1-2-1/1-2-1-2-khromatograficheskiemetody-analiza/khromatografiya/
10. https://pharmacopoeia.regmed.ru/pharmacopoeia/izdanie-15/1/1-2/1-2-1/1-2-1-2-khromatograficheskie-metody-analiza/vysokoeffektivnaya-zhidkost naya-khromatografiya/
11. Rayaprolu B.M., Strawser J.J., Gopal A. Excipients in par enteral formulations: selection considerations and effec tive utilization with small molecules and biologics. Drug development and industrial pharmacy. 2018;44(10):1565 1571. DOI: 10.1080/03639045.2018.1483392.
12. Strickley R.G., Lambert W.J. A review of formula tions of commercially available antibodies. Journal of Pharmaceutical Science. 2021;110(7):2590–2608. DOI: 10.1016/j.xphs.2021.03.017.
Review
For citations:
Minero A.S., Rounova O.B., Fadeikina O.V., Volkova R.A., Ustinnikova O.B. Certified Reference Material for Quantitative Evaluation of Carbohydrate Stabilizers by Ion Exchange HPLC. Journal Biomed. 2025;21(1):26-33. (In Russ.) https://doi.org/10.33647/2074-5982-21-1-26-33
Views:
125
Email this article 
