The stability of cefoselis sulfate in aqueous solutions in accordance with the ICH guidelines for stability testing
DOI:
https://doi.org/10.12923/j.2084-980X/25.3/a.19Słowa kluczowe:
cefoselis sulfate, stability in aqueous solutions, ICH Guidelines, HPLCAbstrakt
The stability of cefoselis sulfate in accordance with the ICH Guidelines for the Stability Testing for Medicinal Substances and Pharmaceutical Products was investigated. The study was conducted at different pH, temperature, oxidative factor and with a varying exposure time. The tests of photostability were also done. Changes in cefoselis sulfate concentration were followed using the HPLC method with UV detection. Cefoselis sulfate was classified depending on the stress conditions applied and data obtained in the study as extremely labile in base pH, very labile in neutral pH, labile in acidic pH and in the presence of an oxidative factor. In the photostability test cefoselis sulfate was classified as photolabile.
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Prawa autorskie (c) 2012 Autorzy
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