In order to harmonize the requirements for the manufacture of domestic reference materials to control quality of pharmaceutical products with international standards, the specialists of FSUE “Endopharm”, in cooperation with the Ural Scientific Research Institute of Metrology – a branch of FSUE “Mendeleev All-Russian Research Institute of Metrology”, an analytical complex was developed to determine the content of components in pharmacologically active substances and excipients (the Complex). By order of the Federal Agency for Technical Regulation and Metrology (Rosstandart), the Complex was approved as a measuring instrument with the assignment of registration number 84849 ‑22.
Making measurements using the Complex allows certification of reference materials in accordance with the State Pharmacopoeia of the Russian Federation and foreign pharmacopoeias, and also fully meets the requirements of the Federal Law “On Ensuring the Uniformity of Measurements” dated June 26, 2008 N 102-FZ.
The Complex is designed to determine the mass fraction and mass concentration of the components of substances and allows separate checking of characteristics that affect the certified values – an error and uncertainty.
To determine the mass fraction of the main substance by the material balance method “100% minus the sum of impurities”, the measurement result is calculated taking into account impurities (sulphated ash, weight loss upon drying, water, impurities, residual organic solvents).
When it is required to obtain the most accurate certified value within a narrow confidence interval, the method based on the material balance is widely used in the world practice in the pharmaceutical and a number of key industries, such as metallurgy, oil and gas industry, agriculture.
The use of reference materials manufactured by FSUE “Endopharm” enables laboratories to show the most important characteristics, such as traceability and uncertainty, established by the international standard GOST ISO/IEC 17025-2019 “General requirements for the competence of testing and calibration laboratories”.
Reference materials manufactured by FSUE “Endopharm” can be used, apart from quality control of pharmaceutical products, for verification and calibration of measuring instruments, quality control of products in veterinary medicine, cosmetics, food industry, and expert activities.
The Complex consists of autonomous blocks, as well as an information processing and managing block – a personal computer with customized software. The software allows full automation of study and carrying out configuration, installation and control of operating parameters, registration of output signals, construction and storage of calibration characteristics, data processing and results recording.
The Complex software provides for the catalogization and formation of a pure substances spectra library, which will be accessible for all users of FSUE “Endopharm” reference materials through a special section on the website www.endopharm.ru.
The manufacture of national reference materials enables significantly reducing dependence on imports, medicines trials terms and their cost.
All reference materials manufactured by FSUE “Endopharm” are recognized as interstate reference materials, which helps increase national exports, strengthen scientific, technical, trade and economic ties.
The range of state reference materials produced by the Enterprise includes 28 titles, of which 17 are used in the manufacture of medicines included in the vital and essential medicines list.
FSUE “Endopharm” is planning to synthetize and certify at least 115 popular titles of state reference materials by the end of 2022.
Comment type is not specified in the component properties.