Authors
Metelev A. V.
Analytical Chemist, Quality Control Laboratory1
Kazakova V. S.
PhD (Pharmacy) Head, Quality Control Department1; Associate Professor, Chair for Pharmaceutical Technology2
Fadeeva D. A.
PhD (Pharmacy), Associate Professor, Chair for Pharmaceutical Technology2
Buzov A. A.
PhD (Technical Scienses), Deputy Director1
Chuev V. P.
Doctor of Technical Scienses, CEO3
1 - LLC «BELPHARMAMED», Belgorod, Russian Federation
2 - Belgorod National Research University, Belgorod, Russian Federation
3 - JSC «VladMiVa» Experimental Plant, Belgorod, Russian Federation
Corresponding Author
Fadeeva Dariya; e-mail: fadeeva@bsu.edu.ru.
Conflict of interest
None declared.
Funding
The study had no sponsorship.
Abstract
The article presents the results of the elaboration of techniques for identification and assay of a new active pharmaceutical substance (API) – 3- (1H-benzimidazol-2-yl) -1,2,2-trimethylcyclopentane-carboxylic acid. To identify the API, the method of IR spectroscopy was used, the assay was carried out using the method of direct acidimetric titration in a medium of glacial acetic acid. Methods were validated in accordance with the requirements of the State Pharmacopoeia of the Russian Federation and are suitable for further use in quality control in the production of 3- (1H-benzimidazol-2-yl) -1,2,2-trimethylcyclopentane-carboxylic acid.
Key words
active pharmaceutical substance (API), 3-(1h-benzimidazol-2-yl) -1,2,2-trimethyl cyclopentancarbonic acid, quality control, identification, assay
DOI
References
1. Pokrovskij M. V., Chuev V.P., Buzov A.A., Kovalenko S.N., Kravchenko A.V. 3-(1N-benzimidazol-2-il)-1, 2, 2-trimetilciklopentankarbonovaya kislota, obladayushchaya kardioprotektornoj aktivnost'yu: Patent 2645356 Rossijskoj Federacii: MPK A 61 K 31/4184, A 61 R 9/10, S 07 D 235/16/; zayavitel' i patentoobladatel' OOO «BELFARMAMED». ¹ 2017129189; zayavl. 15.08.2017, opubl. 21.02.2018, Byul. ¹ 6. 8 s. [3-(1H-benzimidazol-2-yl)-1, 2, 2-trimethylcyclopentanecarboxylic acid with cardioprotective activity: Patent 2645356 of the Russian Federation: IPC A 61 K 31/4184, A 61 R 9/10, C 07 D 235/16/; applicant and patent holder LLC «BELFARMAMED». No. 2017129189; dec. 08/15/2017, publ. 02/21/2018, Bull. No. 6. 8 p.] (In Russ.)
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