Synthetic Genistein: A Possible Active Pharmaceutical Substance for the Development of Radiation Countermeasure Agents

The development of dosage forms of effective radiation countermeasure agents remains an urgent task of modern radiobiology. The purpose of this study is to determine the quality indicators of domestic synthetic genistein as a possible active pharmaceutical substance for the development of radiation countermeasure agents. The material for this study was two samples of genistein synthesized at the SPC Farmzashchita of the Federal Medical Biological Agency of Russia and at the St. Petersburg State Chemical and Pharmaceutical University of the Ministry of Health of Russia, and natural genistein isolated from soybean seed cake (Glycinemax L. Merr.). The quality of synthetic and natural genistein was evaluated using infrared Fourier spectroscopy, nuclear magnetic resonance H1 and C13 spectroscopy, and Raman spectroscopy. It was established that, according to the studied spectra, the studied genistein samples do not differ from each other, the structure of the molecule is confirmed, and there are no additional signals in them. The method of non-aqueous titration of genistein with potentiometric determination of the end point of titration in dimethylformamide medium, which is recommended to be included in the regulatory documentation for a genistein drug substance, has been developed and validated. The method of high-performance liquid chromatography of quantitative determination of genistein for further study of biologically active additives and medicinal products based on it has been developed and tested.