Визначення терміну придатності активного фармацевтичного інгредієнта морфоліній 2-(4-(2-метоксифеніл)-5-(4-піридил)-4Н-1,2,4-тріазол-3-іл)тіо)ацетату

This study determined the shelf life of the active pharmaceutical ingredient (API) morpholinium 2-(4-(2-methoxyphenyl)-5-(4-pyridyl)-4H-1,2,4-triazol-3-yl)thio)acetate by determining its quantitative storage characteristics. Aim. The aim of the work was to determine the shelf life of the API morpholinium 2-(4-(2-methoxyphenyl)-5-(4-pyridyl)-4H-1,2,4-triazol-3-yl)thio)acetate using the accelerated aging method. Materials and methods. The work used the physicochemical method of accelerated aging, as well as the method of spectrophotometry in the UV region (SPECORD 200-222U214 device) to establish quantitative indicators of the API during its storage, the characteristics of the linear dependence and metrological characteristics of the UV-SF method are given using the method of mathematical statistics. API samples were taken using analytical balances KERN AVT 120-5DM. Results. It was established that after the completion of the experimental storage period (at 40 °C), which corresponds to a shelf life of two years (storage at room temperature), the active pharmaceutical ingredient, namely the morpholinium salt of 2-(4-(2-methoxyphenyl)-5-(4-pyridyl)-4H-1,2,4-triazol-3-yl)thio)acetic acid, complies with the requirements of the temporary pharmacopoeial monograph. Based on this, the proposed shelf life in the project is set at two years. Considering that morpholinium 2-(4-(2-methoxyphenyl)-5-(4-pyridyl)-4H-1,2,4-triazol-3-yl)thio)acetate contains a divalent sulfur atom in its structure, it may be susceptible to oxidation. Therefore, medicinal products based on this API should be stored in a place protected from light. Conclusions. The study results provide a basis for asserting that morpholinium 2-(4-(2-methoxyphenyl)-5-(4-pyridyl)-4H-1,2,4-triazol-3-yl)thio)acetate can be stored at room temperature for at least two years without loss of quality.