STABILITY STUDY OF INNOVATIVE PHARMACEUTICAL SUBSTANCE BASED ON THE DERIVATIVE 3,7-DIAZABI- CYCLO [3.3.1] NONANE
Stability is an important indicator of the quality of pharmaceutical substances and drugs, since it ensures the preservation of their therapeutic properties, in most cases for several years in the process of distribution and storage. The shelf life of the medicinal product is established experimentally when stored for a certain time in the conditions and packaging regulated by the regulatory documentation, and as data accumulates, it can be changed both up and down, the main thing is the period of time during which the drug the product fully meets all the requirements of regulatory documentation, in accordance with which it was produced and stored. As a result of stability studies of prototypes of 3 series of a pharmaceutical substance based on a derivative of 3,7-diazabicyclo[3.3.1]non- ane, it is stored for 24 months at a temperature of 15 to 25 ° C in a dry, dark place deviations from the requirements of the specification of normative documentation are revealed. Thus, the optimal recommended storage temperature of a pharmaceutical substance based on a derivative of 3,7-diazabicyclo[3.3.1]nonane is a temperature of 15 to 25 ° C, in a dark place. The results obtained during this experiment will be taken into account in the process of developing a specification for a pharmaceutical substance, and subsequently for a finished dosage form in terms of the choice of analytical methods that can effectively determine the active substance and its decomposition products.