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
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.
2. Mazur I.A., Voloshin N.A., Chekman I.S. et al. // Thiotriazolin. Pharmacological aspects and clinical application // Lviv: Nautilus, 2005. - 144 p.
3. Georgievsky G.V. Physico-chemical methods of quality control of thiotriazoline and standardization of the dosage forms created on its basis: Diss. on the competition uch. degree of candidate pharmac. Sciences / G.V.Georgievsky. - Kharkov, 1995. - 135 p.
4. Georgievsky G.V., Khovanskaya NP, Grizodub A.I. et al. Quality control of drugs based on thiotriazolin // Farmakom, 1995. No. 1, 2. - P. 28–41.
5. Georgievsky G.V., Mazur I.A. Analytical support of the synthesis and creation of finished dosage forms of 1,2.4-triazole derivatives //
The 8th Ukrainian Conference Meeting of the Analitiches of His Holiness for the International Participation / Tezi Conf. - Odes. - 2008. - p. 178
6. Kucherenko L.I., Georgiyevsky G.V., Shapovalova L.I. The development of methods of standardization of the new drug product is cardiotril. // Farmakom. - 2008. - pp. 55–60.
7. Georgievsky G.V. Development of a complex of physico-chemical methods that ensure the creation and quality control of original domestic preparations - derivatives of 1,2,4-triazole / Zaporizky medical journal. - 2011, No. 1. - P. 58–70.
8. Kucherenko L.І.Rozrobka tehnologii і і standardization of tablets lіkarskih drugs on the basis of the last 1,2,4-triazole: author. dis. on the health stage of Dr. pharmac. Sciences / L.І.Kucherenko. - Kharkiv, 2010, 44 p.
9. Egorov A.A., Belenichev I.F., Mazur I.A., Georgievsky G.V. et al. The state of energy metabolism in cerebral ischemia and its modulation by L-lysine derivatives // Ukrainian Science.-Pract. young magazine. - 2011, Spec. vipus - p. 49–50.
10. Patent No. 86668 of Ukraine (2009) Lizin 3-methyl-1,2,4-triazol-5-tioacetate, showing neuroprotective, nootropic, cardioprotective, endoprotective. Anti-oxidant, anti-oxidant, anti-inflammatory, anti-toxic to low toxicity / Mazur I.A., Balunichev I.F., Kolesnik Yu.M., Abramov AV, Kucherenko L.I., Voloshin M.An., Chekman II .S., Mamchur V.I., Gorchakova N.A., Georgievsky G.V., Groshoviy T.A. / Applicant and Patentee TOV "NVO PHARMATRON". Stated on 02/25/2009. Publ. 12.05.2009, Bull. No. 9
11. ICH Topic Q 8 (R 2). - Part I. - Pharmaceutical Development
(EMEA / CHMR / 167068/2004 Note for Guidance on Pharmaceutical Development.
12. СРМР / ICH / 367/96 (ICH Topic Q6A). Criteria for Chemical Substances and Chemical Substances.
13. Nastanova 42-3.2: 2004. - Nastanovi zakostі. Лікарські сооби. Specifications: controls and criteria and criteria / V.Georgієvsky, M.Lyapunov, O.Bezugla and ін. - K., Ministry of Health of Ukraine, 2004. - 38 p.
14. The Rules Governing Medicinal Products in the European Union. Volume 3A: Quality Guidelines. - Guideline 3AQ11a: Specifications and Control Tests on the Finished Product.
15. ICH Topic Q 8. - Part II. - Annex Pharmaceutical Development
(EMEA / CHMR / 167068/2004 Annex to Note for Guidance on Pharmaceutical Development.
16. Nastanova CT-N MOZU 42-4.2: 2011. - Лікарські пособи. Managing rizikov for durability (ICH Q9) / M.Lyapunov, O. Bezugla, O. Solovyov ta іn. - K., Ministry of Health of Ukraine, 2011. - 30 p.
This work is licensed under a Creative Commons Attribution 4.0 International License.