Stability of diluted epinephrine in prefilled syringes for use in neonatology

Objectives The purpose of this study was to determine the chemical stability and sterility of a diluted, ready-to-use solution of epinephrine for premature neonatal emergencies. Methods A commercially available preparation of epinephrine (1 mg/ml) was diluted with pyrogen-free water under sterile conditions. Diluted solution containing 0.1 mg/ml epinephrine was used to fill Luer-lock syringes which were tightly sealed and stored at room temperature or 2-8°C. A high-performance liquid chromatography method was validated in terms of linearity, accuracy, precision, limits of detection and quantitation, intermediate precision and stability indicating capacity and used to assess epinephrine concentration in syringes stored for up to 24 weeks. Current methods were used to check the sterility of the preparation. Results Diluted epinephrine solution in samples stored at room temperature contained 90%-98% of the freshly prepared dilution. Samples stored at 2-8°C showed no degradation. Sterility was maintained in all samples analysed. Conclusion Diluted epinephrine solution stored at room temperature or at 2-8°C is chemically stable and sterile for 24 weeks. The preparation is fully acceptable for intravenous and endotracheal administration in preterm neonates.