Development of a domestic standard sample of vitamin D based on comparative studies of its stability

DOI: https://doi.org/10.29296/25419218-2022-07-05
Issue: 
7
Year: 
2022

E.B. Susyev(1), E.F.Stepanova(1), V.D.Noskova(2)
1-Pyatigorsk Medical and Pharmaceutical Institute – branch of Volgograd State Medical University, Kalinin Av., 11, Pyatigorsk, 357532, Russian Federation;
2-Federal State Budgetary Educational Institution of Higher Education "Ural State Medical University" of the Ministry of Health of the Russian Federation, Repina Street, 3, Yekaterinburg, 620028, Russian Federation

Introduction. The current level of development of the pharmaceutical industry and all its areas, as well as the introduction of evidence-based medicine dictate the improvement and updating of analytical support for scientific research of production cycles. Thus, the analysis of organic compounds today requires the use of physico-chemical methods: including the transition from traditional titration to complex instrument variants using substances of 100% purity – a standard – standard, thanks to which it is possible to ensure the unity of measurements and traceability of the results obtained. Increasing requirements for the purity and individuality of target products have globalized the role of standardization in the creation and production of medicines, as well as intermediate components used in related fields with pharmacy. Material and methods. As the main research models, various types of standard sample materials (imported, Reference Material and own production) are considered in conditions of various storage options: long-term research, meetdom of “Accelerated aging” and stress research. Results. Based on the conducted research and the obtained statistical data, it is proved that the existing material of domestic production, some objects of foreign production, as well as a control sample of an imported standard sample of vitamin D, are stable. The performed studies are able to provide validation of vitamin D production and the unity of measurements related to the production of vitamins in various fields of domestic industry and agriculture Conclusion. Foreign Reference Material models and a substance of domestic production can equally claim to be used in a standard sample with subsequent approval of its type, and accordingly are applicable as a standard sample for pharmaceutical analysis.
Keywords: 
standard sample
vitamin D
industrial technology
pharmaceutical analysis
shelf life
storage conditions
stability
stress studies
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