Open AccessProcedure of matter identification of reference material for composition of azithromycin with use of spectral method
Author(s) -
Vladimir Gegechkori,
N. A. Shulga,
О. Ю. Щепочкина,
Neonila V. Gorokhovets,
А. А. Левко,
Н. Н. Чадова,
В. Н. Шестаков
Publication year - 2021
Publication title -
ètalony. standartnye obrazcy
Language(s) - English
Resource type - Journals
ISSN - 2687-0886
DOI - 10.20915/2687-0886-2021-17-3-21-34
Subject(s) - azithromycin , pharmacopoeia , identification (biology) , computer science , russian federation , risk analysis (engineering) , biochemical engineering , engineering , business , chemistry , medicine , biology , antibiotics , biochemistry , botany , alternative medicine , pathology , economic policy
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.