Determination of the stability of a nonsteroidal anti-inflammatory drug for dogs based on celecoxib

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