Article Text

PDF
Stability of diluted epinephrine in prefilled syringes for use in neonatology
  1. Davide Zenoni1,
  2. Giorgio Priori2,
  3. Cristina Bellan2,
  4. Roberto William Invernizzi3
  1. 1Operative Unit Pharmacia, Azienda Ospedaliera Bolognini, Seriate, Italy
  2. 2Intensive Care Unit, Azienda Ospedaliera Bolognini, Seriate, Italy
  3. 3Department of Neuroscience, Istituto di Ricerche Farmacologiche ‘Mario Negri’, Milan, Italy
  1. Correspondence to Roberto William Invernizzi, Department of Neuroscience, Istituto di Ricerche Farmacologiche ‘Mario Negri’, Via Giuseppe La Masa 19, Milan 20156, Italy; rinvernizzi{at}marionegri.it

Abstract

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.

View Full Text

Statistics from Altmetric.com

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.