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SM ISO690:2012 UNCU, Andrei, VALICA, Vladimir, VÎSLOUH, Oxana, MACAEV, Fliur, UNCU, Livia. Degradarea accelerată a propiltiohinotiadiazolului în cercetarea stabilității. In: Congresul consacrat aniversării a 75-a de la fondarea Universității de Stat de Medicină şi Farmacie „Nicolae Testemiţanu”, 21-23 octombrie 2020, Chişinău. Chişinău: USMF, 2020, p. 684. |
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Congresul consacrat aniversării a 75-a de la fondarea Universității de Stat de Medicină şi Farmacie „Nicolae Testemiţanu” 2020 | ||||||
Congresul "Congresul consacrat aniversării a 75-a de la fondarea Universității de Stat de Medicină şi Farmacie „Nicolae Testemiţanu”" Chişinău, Moldova, 21-23 octombrie 2020 | ||||||
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Pag. 684-684 | ||||||
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Background. Stability research is a key step in assessing the quality and safety of a drug substance. Objective of the study. Evaluation of the stability of propylthiohinothiadiazole by accelerated isothermal degradation and under stress. Material and Methods. Stability testing methodology ICH Topic Q1A (R2); 3 series of propylthioquinothiadiazole in bulk; Shimadzu LC-20AD liquid chromatograph with UV-VIS detector; Perkin Elmer-40 spectrophotometer; thermogravimeter Q200 V24.4 Build 116; solvents, reagents in accordance with the European Pharmacopoeia. Results. Under conditions of oxidative, hydrolytic, thermal, acid-base, photocatalytic stress, it was established by UV-VIS spectrophotometric method that the substance is stable at temperature, humidity and acidic environment. Propylthioquinothiadiazole degrades under the influence of the oxidant and in the basic medium (decreasing the concentration by 3% and 5%). DSC thermal analysis shows that the substance undergoes thermal changes after 1100C. By experimental storage, using "Accelerated degradation" method at 400C and 600C, with the determination of the concentration by the HPLC method, was calculated the shelf life for the substance of 7 years. Conclusion. The results obtained will also be confirmed by real-time stability studies. Currently the substance is stored under normal conditions (250C; 65% RH) for 3 years and 10 months. By now, the drug substance meets all the quality criteria set out in the draft of quality specification. |
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Cuvinte-cheie stability, propylthiohinothiadiazole, Shelf life, stabilitate, propiltiohinotiadiazol, termen de valabilitate |
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