Specialists of FSUE Endopharm in cooperation with UNIIM, a branch of FSUE “VNIIM named after D.I. Mendeleev,” have developed an analytical complex for determining the content of components in pharmacologically active and auxiliary substances.
Tests with the use of the complex make it possible to perform certification of reference samples 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 26.06.2008 N 102-FZ.
The complex is intended to determine the mass fraction and mass concentration of components of substances, with the possibility to check error and uncertainty, the characteristics that affect the certified values.
When determining the mass fraction of the main substance by the material balance method (100% minus the amount of impurities), the measurement result is calculated taking impurities into account (these include sulfate ash, water, residual organic solvents, and mass loss during drying is also considered).
The method based on the material balance is widely used in global pharmaceutics, as well as in a number of other important industries, such as metallurgy, oil and gas industry, agriculture, when the most accurate certified value within a narrow confidence interval is needed.
With the use of reference samples produced by FSUE Endopharm, laboratories are able to demonstrate 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”.
In addition to quality control of pharmaceutical products, reference samples provided by FSUE Endopharm can be used for verification and calibration of measuring instruments, as well as in product quality control in veterinary medicine, cosmetics industry, food industry, and expert examination.
Structurally, a complex consists of autonomous units, as well as an information processing and management unit (a personal computer with dedicated software). The software fully automates the study, and it is possible to configure, set up, and control the operating parameters, register output signals, build and store calibration characteristics, process data, and issue protocols of results.
The functions of the software of the Complex include cataloging and formation of a library of spectra of pure substances, access to which will be opened for all consumers of FSUE Endopharm’s reference samples through a special section at www.endopharm.ru .
The production of domestic reference samples can significantly reduce dependence on imports, the time required for drug testing, and their cost.
All reference materials produced by FSUE Endopharm are recognized as interstate reference samples, which promotes national exports, reinforcing scientific, technical, and trade and economic connections.
The product range of state reference samples produced by the enterprise includes 28 items, of which 17 are used in the production of vital and essential drugs.
FSUE Endopharm plans to synthesize and certify at least 115 state reference samples of in-demand medicines by the end of 2022.