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Long-term Physicochemical Stability of Concentrated Solutions of Noradrenaline Bitartrate in Polypropylene Syringes for Administration in the Intensive Care Unit

Author(s):  Lardinois Benjamin, Pector Johan, Delcave Charlotte, Soumoy Laura, Jamart Jacques, Bihin B, Hecq Jean-Daniel, Galanti Laurence M

Issue:  Jul/Aug 2018 - Volume 22, Number 4
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Abstract:  Intensive care units use drug solutions within higher concentrations to avoid fluid overload. The purpose of this study was to evaluate the physicochemical stability of concentrated solutions of noradrenaline bitartrate in polypropylene syringes during 30 days of storage at 5ÅãC Å} 3ÅãC. Five 50-mL syringes containing 0.240 mg/mL of noradrenaline bitartrate in 0.9% sodium chloride were prepared and stored at 5ÅãC Å} 3ÅãC during 30 days. Immediately after preparation and periodically during the storage, noradrenaline concentrations were measured by high-performance liquid chromatography. Spectrophotometric absorbance at different wavelengths, pH measurement, and microscopic observations were also performed. The results showed that all solutions were physicochemically stable during the entire storage period at 5ÅãC Å} 3ÅãC, and no color change, turbidity, precipitation, opacity, significant pH variations, nor optic densities were observed. Microscopic analysis was used to determine if there was any formation of crystals. The concentration of noradrenaline was not found to decrease during the 30 days of storage. Solutions of noradrenaline bitartrate 0.240 mg/mL in syringes of 0.9% sodium chloride were physically and chemically stable for at least 30 days when stored in syringes at 5ÅãC Å} 3ÅãC and may be prepared in advanced by a centralized intravenous additive service.

Related Keywords: Benjamin Lardinois, MD, Johan Pector, MLT, Charlotte Delcave, PharmD, Laura Soumoy, PharmD, Jacques Jamart, MD, MSc, B. Bihin, MSc, Jean-Daniel Hecq, PharmD, PhD, Laurence M. Galanti, MD, PhD, noradrenaline, alpha-adrenergic agonist, norepinephreine, catecholamine, beta-adrenergic agonist, vasopressor, hydrodynamic shock, circulatory failure, sympathetic nervous system, physical stability, chemical stability, intensive care unit, ICU, hypotension, low blood pressure, emergency medicine


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