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

  • G.V. Georgievskiy -
Keywords: quality critical parameters, pharmaceutical development, high performance liquid chromatography (HPLC),validation, lysine-3-methyl-1,2,4-triazolyl-5-thioacetate (hereinafter referred to as lysiniy)


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.

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 ОС was shown.

The procedures proposed were used for the pharmaceutical development of lysiniy”preparation.


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How to Cite
Georgievskiy, G. (2019). 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. Farmatsevtychnyi Zhurnal, (2), 27-42. Retrieved from
Original Articles