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Physicochemical Stability of Norepinephrine Bitartrate in Polypropylene Syringes at High Concentrations for Intensive Care Units

Physicochemical Stability of Norepinephrine Bitartrate in Polypropylene Syringes at High Concentrations for Intensive Care Units

E D'Huart, J Vigneron, I Clarot, B Demore

Ann Pharm Fr. 2019 May;77(3):212-221.

PMID: 30803767

Abstract:

Objectives:
Norepinephrine is usually used in emergency situations such as in intensive care units (ICUs) for the restoration of blood pressure. The objective was to study the stability of highly-concentrated solutions of norepinephrine at 0.50mg/mL and 1.16mg/mL, diluted in glucose 5% (G5%) in polypropylene syringes, protected or not from light, up to 48h.
Materials and methods:
Chemical stability was analysed by high-performance liquid chromatography coupled to photodiode array detection at each time of the analysis. The method was validated according to the International Conference on Harmonisation Q2(R1). Physical stability was evaluated by visual and subvisual inspection. Three syringes for each condition were prepared. At each time of the analysis, three samples were analysed for each syringe. pH values were evaluated at each moment of the analysis.
Results:
Solutions of norepinephrine at 0.50 and 1.16mg/mL, diluted in G5%, with or without protection from light, retained more than 95.0% of the initial concentration after a 48-hour storage at 20-25°C. No visual and subvisual modification occured during the stability study. No degradation product appearing during the stressed degradation was observed during the study but an additional peak with a relative retention at 0.66 was observed and constant. This peak was identified as 5-hydroxymethylfurfural, a degradation product of glucose.
Conclusion:
Norepinephrine diluted in G5% at 0.50mg/mL and 1.16mg/mL was physically and chemically stable over a period of 48hours at room temperature. These stability data of highly concentrated solutions provide additional knowledge to assist intensive care services in daily practice.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP108341180-A	Norepinephrine bitartrate		108341-18-0	Price

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