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Ujian Kestabilan Arrhenius×Faktor Keserupaan f1/f2 Pembubaran×
BidangFarmakologiFarmakologi
KeluargaProcess / pipelineProcess / pipeline
Tahun asal18891996
PengasasSvante ArrheniusJames Moore and Hector Flanner
Jenisshelf-life predictionsimilarity testing
Sumber perintisArrhenius, S. (1889). Über die Reaktionsgeschwindigkeit bei der Inversion von Rohrzucker durch Säuren. Zeitschrift für Physikalische Chemie, 4, 226-248. link ↗Moore, J. W., & Flanner, H. H. (1996). Mathematical comparison of dissolution profiles. Pharmaceutical Technology, 20(6), 64-74. link ↗
AliasArrhenius model, shelf-life prediction, degradation kineticsf1, f2, similarity factor
Berkaitan33
RingkasanArrhenius stability testing predicts pharmaceutical product shelf-life by conducting accelerated degradation studies at elevated temperatures and using the Arrhenius equation to extrapolate to storage conditions. Based on Svante Arrhenius's 1889 equation relating reaction rate to temperature, this method is regulatory standard for establishing expiration dates.The f1 and f2 factors are dimensionless statistical measures developed by Moore and Flanner to quantify the similarity between two dissolution profiles. Adopted by regulatory agencies (FDA, EMA) as the gold standard for comparing dissolution curves, these factors enable rapid assessment of whether formulation changes significantly impact drug release.
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ScholarGateBandingkan kaedah: Arrhenius Stability · Dissolution f1/f2 Similarity. Dicapai 2026-06-19 daripada https://scholargate.app/ms/compare