@article{Georgievskiy_2019, title={Assessment procedures of quality critical parameters in the pharmaceutical development of the substance designated lysiniy or lysine-3-methyl-1,2,4-triazolyl-5-thioacetate and 2.5 % injection thereof}, url={https://pharmj.org.ua/index.php/journal/article/view/528}, abstractNote={<p>The procedures for determination of quality critical parameters for the novel original substance of lysine-3-methyl-1,2,4-triazolyl-5-thioacetate (lysiniy) and its 2.5 % injection have been developed and validated. The procedure enables both to monitor quality of a molecule by allowable limits for process-related impurities and to study the stability of the substance by identifying critical parameters of decomposition products content under stress conditions.</p> <p>A method of quantification of 2.5 % lysiniy injection was proposed and validated and capability to manufacture ampoules using sterilization by sterile filtration processes at 120 <sup>О</sup>С was shown.</p> <p>The procedures proposed were used for the pharmaceutical development of lysiniy”preparation.</p&gt;}, number={2}, journal={Farmatsevtychnyi zhurnal}, author={Georgievskiy, G.V.}, year={2019}, month={Mar.}, pages={27-42} }