Chemical and visual stability of amphotericin B in 5% dextrose injection stored at 4 degrees C for 35 days

Abstract

The chemical and visual stability of amphotericin B in 5% dextrose injection under refrigeration was assessed. Three admixtures of amphotericin B 0.1 mg/mL in 5% dextrose injection and three admixtures of amphotericin B 0.25 mg/mL in 5% dextrose injection were aseptically prepared in polyvinyl chloride (PVC) bags. Immediately after preparation (at time zero), six 5-mL samples were aseptically transferred from each admixture to sterile collection tubes. Three of the samples from each admixture were quick-frozen for later assay by stability-indicating high-performance liquid chromatography (HPLC), and the other three were immediately assessed for pH. Each of the six admixtures was also assessed visually under fluorescent light and 2x magnification for color change, turbidity, gas evolution, and precipitation. The admixtures were stored in PVC bags at 4 degrees C and protected from light. Six 5-mL samples were withdrawn from each admixture at 10, 21, and 35 days. Three of the samples from each admixture were assessed for pH, and three were quick-frozen for subsequent HPLC assay. There was no substantial loss or deterioration of amphotericin B during the 35-day study. At no time was the mean concentration of amphotericin B in the samples less than 96.4% of the concentrations at time zero for the 0.1-mg/mL samples or less than 96.6% of the time zero concentrations for the 0.25-mg/mL samples. There were no appreciable changes in pH, and there was no visual evidence of instability in any of the samples.(ABSTRACT TRUNCATED AT 250 WORDS)