[The development of the physicochemical characteristics of the new original nootropic substance TST-9].

Physicochemical properties of the original pharmaceutical substance TST-9 based on the 3,7-diazabicyclo[3.3.1]nonane derivative with the chemical name IUPAC 6-[4methoxy-3-(1H-pyrazol-1-ylmethyl) benzyl]-1,11-dimethyl-3,6,9-triazatricyclo[7.3.1.1]tetradecane-4,8,12-trion, were studied. TST-9 is used as an active substance for the development of the composition and technology for the preparation of an innovative oral drug. The pharmaceutical substance TST-9 is an amorphous white powder, odorless, soluble in chloroform, acetonitrile, methylene chloride, acetone, dimethyl sulfoxide, dimethylformamide and alcohol, sparingly soluble in diethyl ether, dioxane and is very slightly soluble in water, hexane, and heptane. The melting point ranged from 94°C to 96°C without visible decomposition of the substance. The microbiological purity corresponds to category 2.2. Residual organic solvents in the form of chloroform did not exceed 0.006%. The amount of impurities was not more than 0.15%. The loss in mass upon drying was not more than 0.5%. The "identity" was confirmed using nuclear magnetic resonance spectroscopy and HPLC with UV detection. The data obtained in the study will contribute to the further development of the dosage form, the choice of the route of administration and the dosage regimen, as well as the selection of analytical methods for analyzing the quality of the finished dosage form and the effective, high-precision determination of the content of the active substance and its likely decay products. Vpervye izucheny fiziko-khimicheskie svoĭstva original'noĭ farmatsevticheskoĭ substantsii TST-9 na osnove proizvodnogo 3,7-diazabitsiklo[3.3.1]nonana s khimicheskim nazvaniem IUPAC 6-[4-metoksi-3-(1N-pirazol-1-ilmetil) benzil]-1,11-dimetil-3,6,9-triazatritsiklo[7.3.1.1]tetradekan-4,8,12-triona, ispol'zuemoĭ v kachestve deĭstvuiushchego veshchestva dlia razrabotki sostava i tekhnologii polucheniia innovatsionnogo lekarstvennogo preparata dlia peroral'nogo primeneniia. V rezul'tate issledovaniĭ bylo ustanovleno, chto farmatsevticheskaia substantsiia TST-9 predstavliaet soboĭ amorfnyĭ poroshok belogo tsveta bez zapakha, rastvorimyĭ v khloroforme, atsetonitrile, khloristom metilene, atsetone, dimetilsul'fokside, dimetilformamide i spirte, malo rastvorim v diétilovom éfire, dioksane. Ochen' malo rastvorim v vode, geksane, geptane. Temperatura plavleniia ot 94°S do 96°S bez vidimogo razlozheniia veshchestva. Mikrobiologicheskaia chistota sootvetstvuet kategorii 2.2. Ostatochnye organicheskie rastvoriteli v vide khloroforma ne bolee 0,006%. Summa postoronnikh primeseĭ sostavila ne bolee 0,15%. Poteria v masse pri vysushivanii sostavila ne bolee 0,5%. Dlia izucheniia pokazatelia “Podlinnost'” provodili sniatie spektrov s ispol'zovaniem metoda spektroskopii iadernogo magnitnogo rezonansa i VÉZhKh s UF-detektirovaniem. Ustanovlennye v khode issledovaniia dannye budut sposobstvovat' dal'neĭsheĭ razrabotke lekarstvennoĭ formy, vyboru puti vvedeniia i rezhima dozirovaniia, a takzhe vyboru analiticheskikh metodov dlia analiza kachestva gotovoĭ lekarstvennoĭ formy i éffektivnogo.