Improvement of the State Primary Standard in the Field of Organic Analysis GET 208

In the context of the rapid development of the Russian pharmaceutical industry, there is an urgent need to improve the State Primary Standard for the units of mass (molar) fraction and mass (molar) concentration of organic components in liquid and solid substances and materials based on liquid and gas chromatography-mass spectrometry with isotope dilution and gravimetry (GET 208).As a result of the improvement of GET 208 carried out in 2023, a new installation based on the highperformance liquid chromatography/high-resolution mass spectrometry method was included in the standard. Thus, the functionality of the GPE was expanded in accordance with the current requirements of the domestic industry and for the purpose of Russia’s successful participation in international comparisons in the field of organic analysis now and in the medium term.The article presents materials on the study of the capabilities of the new installation for solving various measurement problems in the field of organic analysis, describes specific analytical techniques and measurement methods, and provides experimental data and summarized results. Based on the completed studies, the metrological characteristics of GET 208 have been improved in terms of reproducing units of mass (molar) fraction of the main component in pure organic substances, mass fraction of organic components in solutions and materials.Improvement of GET 208 made it possible to create a scientific, methodological and instrumental basis for reproducing measurement units for a wide range of organic compounds.

State Primary Standard, organic analysis, mass balance method, high-resolution mass spectrometry, pure organic substances, active pharmaceutical substances