Physico-chemical stability of noradrenaline bitartrate in polypropylene syringe for administration in the Intensive Care Unit
6 October 2017B. Lardinois, J. Pector, Ch. Delcave, M, Godet, J. Jamart, B. Bihin, L. Soumoy, J-D. Hecq, L. Galanti Drug Stability Research Group, CHU UCL Namur, Yvoir, Belgique
The intensive Care Unit (ICU) use drug solutions within higher concentration to avoid fluid overload.
To evaluate the physico-chemical stability of concentrated solution of noradrenaline bitartrate in polypropylene syringe during 30 days at 5 ± 3°C.
Material and methods
Five syringes of 50 ml, containing 0.24 mg/ml of noradrenaline bitartrate in 0.9 % NaCl were prepared and stored at 5 ± 3°C during 30 days. Immediately after preparation and periodically during the storage, noradrenaline concentrations was measured by a high-performance liquid chromatography (HPLC). Spectrophotometric absorbance at different wavelengths, pH measurement and microscopic observations were also performed.
All solutions were physically stable during the whole period storage at 5 ± 3°C: no color change, turbidity, precipitation or opacity at visual observation. No significant pH variations or optic densities were observed. Any crystals were seen by microscopic analysis. Solutions are considered chemically stable as the lower limit of the 95 % unilateral confidence interval on the mean remained above 90 % of the initial concentration for at least 30 days.
Solutions of noradrenaline bitartrate 0.24 mg/ml in syringe of 0.9 % NaCl are physically and chemically stable for at least 30 days when stored in syringes at 5 ± 3°C and may be prepared in advanced by a CIVA.