Modern Approaches to the Development of Standard Samples of Drugs

Shchepochkina, O. Yu.; Gegechkori, Vladimir; Прокофьева, Вера Ивановна; Chepilo, D. A.; Левко, А. А.; Чадова, Н. Н.; Шестаков, В. Н.

doi:10.1007/s11094-020-02267-y

Cited by 8 publications

(1 citation statement)

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“…Исследования фармакокинетики лекарственных препаратов в фун даментальных и прикладных исследованиях, прове дение терапевтического мониторинга для дальнейшей коррекции фармакотерапии, химико-токсикологиче ском анализе для определения дальнейшей детоксикационной терапии и установления факта смерти от то го или иного лекарственного препарата. Таким обра зом, вопрос создания собственной системы обраще ния и контроля за стандартными образцами различного уровня на территории Российской Федерации является актуальным вопросом современной науки и фармацев тической промышленности [1][2].…”

Section: In New Medicinal Products Development As Well As Actualisation O F Assessment Approaches O F Medicinal Products In Circulation Tunclassified

Procedure of matter identification of reference material for composition of azithromycin with use of spectral method

et al. 2021

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In new medicinal products development, as well as actualisation of assessment approaches of medicinal products in circulation, the development of quality control procedures remains one of the most important issues in standardisation. Besides, such development should include using reliable, accurate and sensitive physicochemical methods which determine the need development and implementation of reference materials. This paper discusses the development of reliable methods for identifying the structure of azithromycin, which will guarantee the purity of the reference material, as well as adequately and unambiguously choose a method of quantitative determination in accordance with the current requirements of regulatory acts, and according to the Pharmacopoeia of the Russian Federation of the XIV Edition.

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Section: In New Medicinal Products Development As Well As Actualisation O F Assessment Approaches O F Medicinal Products In Circulation Tunclassified