ТЕХНОЛОГИЯ ПОЛУЧЕНИЯ СТАНДАРТНОГО ОБРАЗЦА РЕТИНОЛА ПАЛЬМИТАТА, ВЫДЕЛЕННОГО ИЗ ПРИРОДНОГО СЫРЬЯ, ОПРЕДЕЛЕНИЕ ОСНОВНЫХ ПОКАЗАТЕЛЕЙ, ХАРАКТЕРИЗУЮЩИХ ЕГО КАЧЕСТВО

Abstract

This article discusses the issues of creating a standard sample (CO) with the use of a substance obtained from natural raw materials as a starting component, using the principles of lean manufacturing and affecting the problem of the production of domestic raw materials. The paper also discusses issues related to the standardization of the finished product, starting from the stage of choosing the material of the CO and ending with control at the stage of forming the material stock of products in a warehouse. As the main model of the study, a material with retinol palmitate isolated from natural raw materials is used. We have used technological techniques for the production of the product under development with the use of step-by-step, starting from the stage of CO preparation, stability control according to the indicator "Uniformity", which in turn is one of the main quality characteristics. Classical manufacturing techniques of pharmaceutical products were used, quantitative and qualitative determination methods, high-performance liquid chromatography (HPLC) at a wavelength of 326 nm and IR spectroscopy in the radiation range of the spectrum from 4000 to 400 cm-1 were used to control the quality of the initial component. A variant of the technological scheme for the production of vitamin A CO has been considered, this technology has been tested, and the received applicant has been standardized according to the main compliance indicators. The developed SO allows, when conducting chemical research, to ensure metrological comparability and convergence of the analysis results between tests conducted not only by different chemical experts, but also between different laboratories and at different times, it is possible only with the use of measuring instruments of a standard sample (SO) with the appropriate certified characteristic for calibration. The use of CO in conformity assessment is one of the first conditions in the work of the laboratory for the recognition of its test results as reliable.