THE STUDY OF METROLOGICAL CHARACTERISTICS OF THE OBTAINED SUBSTANCES OF FAT-SOLUBLE VITAMINS BY INTERLABORATORY COMPARISON TESTS

Abstract

Relevance. This article discusses the possibility of using substances isolated from natural raw materials of fat-soluble vitamins retinol-palmitate (vitamin A), cholecalciferol (vitamin D3), tocopherol-acetet (vitamin E) in order to create domestic standard samples of approved type (SSS). The use of SSS in analytical practice, as well as in scientific research, makes it possible to ensure the accuracy and reliability of experimental results, to ensure the traceability of the result when performing analyses within the framework of repeatability and reproducibility (precision). The paper addresses issues related to the production and standardization of domestic pharmaceutical substances, as well as issues of standardization and conformity assessment of finished products of the pharmaceutical industry and other sectors of the national economy (food industry, agriculture, perfumery and cosmetics, the industry of production of goods for children's practice, etc.). The purpose of the work. To establish the quantitative content of fat-soluble vitamins A, D3, E, in the obtained substances claiming the status of SS with the approved type, as well as to determine their stability and uniformity by means of interlaboratory comparison tests (hereinafter referred to as ICT). Material and methods. The quantitative content of fat-soluble vitamins in the obtained substances was assessed by HPLC in 6 accredited analytical laboratories. The results were processed by evaluating the data provided for the presence of outliers and quasi-outliers using the Kohren, Grubbs and Mandel method. Results. The conducted studies under the comparison program showed that the results of the quantitative determination of the obtained vitamins are within the norms of the certified characteristic "Mass fraction of vitamin, %" in relation to the content of the determined characteristic in reference substances of imported production. Conclusions. As a result of the statistical data obtained, we have proved that the substances obtained from fat-soluble vitamins A, E, D3 comply with regulatory requirements based on the results of interlaboratory comparisons and can be recommended for the manufacture of domestic SS with the approval of their type, and it can also be assumed that the manufacturing processes of domestic and imported SS are harmonized. The quality of domestic SS is at an identical level with respect to foreign SS, but each is produced exclusively in the legal field of the manufacturer's state and is legitimate in its territory of application, which once again confirms the high need to create a domestic reference pharmaceutical base.