Long-Term Stability of 5-Fluorouracil in 0.9% Sodium Chloride after Freezing, Microwave Thawing, and Refrigeration

Abstract

ABSTRACT

Objective: To investigate the stability of 5-fluorouracil diluted in 0.9% sodium chloride (normal saline [NS]) after freezing, microwave thawing, and storage for 28 days at 5°C ± 3°C.

Methods: Polyvinylchloride (PVC) infusion bags (n = 5) containing 5-fluorouracil 800 mg/100 mL were frozen for 79 days at –20°C. The bags were then thawed in a microwave oven and stored at 5°C ± 3°C for 28 days. The concentration of 5-fluorouracil was measured by highperformance liquid chromatography. Visual and microscopic inspections were performed and pH was measured periodically during storage. Solutions were considered stable if the lower limit of the 95% confidence interval of the concentration versus time profile remained greater than 90% of the initial concentration.

Results: No colour change or precipitation was observed in any of the solutions. Slight changes in pH were observed during refrigeration. 5-Fluorouracil solutions were stable during storage at 5°C ± 3°C for 28 days, as indicated by the results of high-performance liquid chromatography.

Conclusion: 5-Fluorouracil 8 mg/mL in NS may be prepared in advance, frozen and stored in PVC bags, and thawed before use. The solutions remained stable after freezing at –20°C for 79 days followed by storage at 5°C ± 3°C for up to 28 days.