Hospital Pharmacy - April 2018 - 73

742516
letter2017

HPXXXX10.1177/0018578717742516Hospital PharmacyDeAngelis et al

Letter to the Editor

Stability of 2 mg/mL Adenosine
Solution in Polyvinyl Chloride and
Polyolefin Infusion Bags

Hospital Pharmacy
2018, Vol. 53(2) 73-74
© The Author(s) 2017
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https://doi.org/10.1177/0018578717742516
DOI: 10.1177/0018578717742516
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Michael DeAngelis1, Alexander Ferrara1, Kaleigh Gregory1,
Kimberly Zammit2, and Fang Zhao1

Abstract
Adenosine is a potent endogenous mediator of vasodilation. Compounded sterile solutions of adenosine are used in cardiac
catheterization lab to perform stress tests on the heart. These tests are used to determine the fractional flow reserve (FFR)
and are commonly used in the management and diagnosis of cardiovascular conditions. The purpose of this study was to assess
the physical and chemical stability of 2 mg/mL adenosine in 0.9% Sodium Chloride Injection, USP in polyvinyl chloride [PVC])
and polyolefin infusion bags stored at room temperature (20°C-25°C) and under refrigeration (2°C-8°C). The compounding
and analytical methods used in this study were very similar to those described in the prior publications from the authors'
laboratory. To ensure a uniform starting concentration of all stability samples, a batch of 2 mg/mL adenosine solution was
prepared and then packaged into empty PVC and polyolefin infusion bags. These stability samples were prepared in triplicate for
each bag type and storage temperature (a total of 12 samples). The infusion bag samples were assessed for stability immediately
after preparation and after 1 day, 3 days, 7 days, and 14 days. At each time point, the infusion bags were first visually inspected
against a light background for color change, clarity, and particulates. Aliquots were drawn from each sample at each time point
for pH analysis and high-performance liquid chromatography (HPLC) analysis. Over 14 days of storage at room temperature
or refrigeration, no considerable change in visual appearance or pH was observed in any bags. All samples retained 90% to
110% of the initial drug concentration. No significant degradation peaks were observed in the HPLC chromatograms.
Keywords
cardiovascular, cardiac agents, drug stability, drug information

Purpose
Adenosine is a potent endogenous mediator of vasodilation.
Compounded sterile solutions of adenosine are used in cardiac
catheterization lab to perform stress tests on the heart. These
tests are used to determine the fractional flow reserve (FFR)
and are commonly used in the management and diagnosis of
cardiovascular conditions.1 In previous studies conducted
in the authors' laboratory, stability and compatibility was
established for 10 to 220 µg/mL adenosine solutions in commonly used intravenous (IV) diluents and infusion bags.2,3
The first study conducted assessed adenosine 50, 100, and
220 µg/mL solutions in polyvinyl chloride (PVC) infusion
bags containing 0.9% sodium chloride injection or 5% dextrose injection stored at room temperature (23°C-25°C) or
under refrigeration (2°C-8°C).1 The second study conducted
assessed adenosine 10 and 50 µg/mL solutions in polyolefin
infusion bags using both diluents and storage conditions in
the first study.2 A forced-degradation study was conducted in
Almagambetova et al.3 Neither study found any significant
signs of degradation or loss. This study was a continuation of
the previous studies but at a higher adenosine concentration

of 2 mg/mL. This high concentration became necessary due
to the flow rate limitation on certain IV infusion pumps used
for FFR lab procedures. The purpose of this study was to
assess the physical and chemical stability of 2 mg/mL adenosine in 0.9% Sodium Chloride Injection, USP in PVC) and
polyolefin infusion bags stored at room temperature
(20°C-25°C) and under refrigeration (2°C-8°C).

Methods
The compounding and analytical methods used in this study
were very similar to those described in the prior publications
from the authors' laboratory.2,3 The main differences are
noted below. Adenosine Injection, USP, 90 mg/30 mL vials
from Teva (NDC# 0703-8777-01, Lot# 31320652B) were
1

Wegmans School of Pharmacy, Rochester, NY, USA
Buffalo General Medical Center, NY, USA

2

Corresponding Author:
Michael DeAngelis, Wegmans School of Pharmacy, 3690 East Ave,
Rochester, NY 14618, USA.
Email: mjd08205@sjfc.edu
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