Determination of the stability of a nonsteroidal anti-inflammatory drug for dogs based on celecoxib DOI Creative Commons
Р. М. Сачук, V. M. Hunchak,

M. L. Kondratyuk

et al.

Ukrainian Journal of Veterinary and Agricultural Sciences, Journal Year: 2025, Volume and Issue: 8(1), P. 44 - 48

Published: April 23, 2025

Stability studies are an important task in developing finished veterinary medicinal products. The stability of medicines ensures that their therapeutic properties preserved for several years storage. should be under the close attention developer, given state control bodies do not check this indicator, and it is manufacturer's responsibility. In order to obtain data on change quality developed solution injection based celecoxib over time, influence various environmental factors, establish recommended storage conditions, tests resulting drug were conducted. As a result study, was proposed shelf life 2 28 days after first puncture stopper dark glass bottle at temperature 25 ± °C humidity 60 5 %, original packaging. Chromatograms demonstrate high similarity between standard sample if prominent peaks coincide retention time intensity. peak spectra confirm identity test sample. difference may indicate possible degradation or presence impurities. Further will next stage pre-registration testing aimed section “Data reflecting risk assessment environment”, which mandatory material part “Chemical, pharmaceutical biological documentation” dossier drug. Instructions created dispose expired defective batches drug, preventing harmful effects.

Language: Английский

Determination of the stability of a nonsteroidal anti-inflammatory drug for dogs based on celecoxib DOI Creative Commons
Р. М. Сачук, V. M. Hunchak,

M. L. Kondratyuk

et al.

Ukrainian Journal of Veterinary and Agricultural Sciences, Journal Year: 2025, Volume and Issue: 8(1), P. 44 - 48

Published: April 23, 2025

Stability studies are an important task in developing finished veterinary medicinal products. The stability of medicines ensures that their therapeutic properties preserved for several years storage. should be under the close attention developer, given state control bodies do not check this indicator, and it is manufacturer's responsibility. In order to obtain data on change quality developed solution injection based celecoxib over time, influence various environmental factors, establish recommended storage conditions, tests resulting drug were conducted. As a result study, was proposed shelf life 2 28 days after first puncture stopper dark glass bottle at temperature 25 ± °C humidity 60 5 %, original packaging. Chromatograms demonstrate high similarity between standard sample if prominent peaks coincide retention time intensity. peak spectra confirm identity test sample. difference may indicate possible degradation or presence impurities. Further will next stage pre-registration testing aimed section “Data reflecting risk assessment environment”, which mandatory material part “Chemical, pharmaceutical biological documentation” dossier drug. Instructions created dispose expired defective batches drug, preventing harmful effects.

Language: Английский

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