Hospital Pharmacy - September 2017 - 570

721121

research-article2017

HPXXXX10.1177/0018578717721121Hospital PharmacyVan Matre et al

Article

Extended Stability of Epinephrine
Hydrochloride Injection in Polyvinyl
Chloride Bags Stored in Amber
Ultraviolet Light-Blocking Bags

Hospital Pharmacy
2017, Vol. 52(8) 570-573
© The Author(s) 2017
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https://doi.org/10.1177/0018578717721121
DOI: 10.1177/0018578717721121
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Edward T. Van Matre1, Kang C. Ho2, Clark Lyda2,
Beth A. Fullmer2, Alan R. Oldland2, and Tyree H. Kiser1

Abstract
Objective: The objective of this study was to evaluate the stability of epinephrine hydrochloride in 0.9% sodium chloride
in polyvinyl chloride bags for up to 60 days. Methods: Dilutions of epinephrine hydrochloride to concentrations of 16 and
64 µg/mL were performed under aseptic conditions. The bags were then placed into ultraviolet light-blocking bags and
stored at room temperature (23°C-25°C) or under refrigeration (3°C-5°C). Three samples of each preparation and storage
environment were analyzed on days 0, 30, 45, and 60. Physical stability was performed by visual examination. The pH was
assessed at baseline and upon final degradation evaluation. Sterility of the samples was not assessed. Chemical stability of
epinephrine hydrochloride was evaluated using high-performance liquid chromatography. To determine the stability-indicating
nature of the assay, degradation 12 months following preparation was evaluated. Samples were considered stable if there was
less than 10% degradation of the initial concentration. Results: Epinephrine hydrochloride diluted to 16 and 64 µg/mL with
0.9% sodium chloride injection and stored in amber ultraviolet light-blocking bags was physically stable throughout the study.
No precipitation was observed. At days 30 and 45, all bags had less than 10% degradation. At day 60, all refrigerated bags had
less than 10% degradation. Overall, the mean concentration of all measurements demonstrated less than 10% degradation at
60 days at room temperature and under refrigeration. Conclusion: Epinephrine hydrochloride diluted to 16 and 64 µg/mL
with 0.9% sodium chloride injection in polyvinyl chloride bags stored in amber ultraviolet light-blocking bags was stable up
to 45 days at room temperature and up to 60 days under refrigeration.
Keywords
epinephrine hydrochloride, sodium chloride, stability, injections, storage, concentration

Introduction
Epinephrine hydrochloride is a sympathomimetic agent and
replicates the actions of the sympathetic nervous system.1
Its potent β1, β2, and α1 agonist properties lead to vasoconstriction and increase cardiac inotropy and chronotropy.2
Due to these effects, epinephrine hydrochloride is commonly used for hemodynamic support in a variety of disease states particularly when bradycardia is present.3-5
Epinephrine hydrochloride can be administered as an intramuscular injection, an intravenous bolus, and/or intravenous infusion. Concentrated epinephrine hydrochloride,
typically 1:1000 concentration (1 mg/mL), must be further
diluted for intravenous administration. Epinephrine hydrochloride for intravenous infusion is commonly diluted to
concentrations ranging from 16 to 64 µg/mL.
Epinephrine contains a catechol moiety which is susceptible to oxidative reactions catalyzed by ultraviolet light,

oxygen, increases in temperature, and basic conditions.6
Efforts to mitigate these degradation mechanisms include
temperature control, minimizing air introduction during
compounding, and storage of compounded solution within
amber ultraviolet light-blocking bags. Previous stability
studies have shown epinephrine hydrochloride at concentrations from 25 to 100 µg/mL are stable for at least 30 days
within polyvinyl chloride bags at room temperature and
under refrigeration.7 However, no stability-indicating studies
1

University of Colorado, Aurora, USA
University of Colorado Hospital, Aurora, USA

Corresponding Author:
Tyree H. Kiser, Associate Professor, Department of Clinical Pharmacy,
Skaggs School of Pharmacy and Pharmaceutical Sciences, University of
Colorado, Anschutz Medical Campus, 12850 E. Montview Blvd, Mail Stop
C238, Aurora, CO 80045, USA.
Email: ty.kiser@ucdenver.edu

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