Research stability of “Uronefron” tablets

V. L. Shevina, N. V. Khokhlenkova, M. I. Borshchevska, V. A. Konovalenko

Abstract


The study of medicines stability is one of the fundamental issues in quality assurance system. In accordance with developed countries current legislation, the rules of Good Manufacturing Practice, one of the responsibilities of the manufacturer is study of stability, which must be carried out at the stage of active substance and medication development.                                              Aim. To conduct a study of long-term and accelerated stability of tablets “Uronefron”.                                                                                                  Results. The article presents the stability study results of “Uronefron” tablets for three experimental batches for 6 months under accelerated tests at the temperature of (40 ± 2) °C and relative humidity of (75 ± 5) % and under conditions of long-term tests at the temperature of (25 ± 2) °C and relative humidity of (60 ± 5) %. A study was conducted to investigate the photostability of the medicine.                                                                                      Conclusions. It is confirmed the compliance of the medicinal drug with the requirements of the specification over time under the influence of temperature, humidity and light.


Keywords


“Uronefron” tablets; shelf life; storage conditions; stability; photostability

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DOI: https://doi.org/10.24959/uekj.17.33

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Abbreviated key title: Upr. ekon. zabezp. âkostì farm.

ISSN 2519-8807 (Online), ISSN 2311-1127 (Print)