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Evaluation of the maximum beyond-use-date stability of regular human insulin extemporaneously prepared in 0.9% sodium chloride in a polyvinyl chloride bag

Authors Rocchio MA, Belisle CD, Greenwood BC, Cotugno MC, Szumita PM

Received 20 July 2013

Accepted for publication 26 August 2013

Published 11 October 2013 Volume 2013:6 Pages 389—392

DOI https://doi.org/10.2147/DMSO.S51843

Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 3


Megan A Rocchio, Caryn D Belisle, Bonnie C Greenwood, Michael C Cotugno, Paul M Szumita

Department of Pharmacy, Brigham and Women's Hospital, Boston, MA, USA

Background: Regular human insulin 100 units added to a sufficient quantity of 0.9% sodium chloride, to yield a total volume of 100 mL within a polyvinylchloride bag, is accepted to be stable for 24 hours due to physical denaturation and chemical modification. The objective of this study was to evaluate the extended stability of such extemporaneously prepared regular human insulin, stored under refrigeration, to the maximum beyond-use-date allowed by United States Pharmacopeia chapter 797.
Methods: At time “0” three admixtures of regular human insulin were prepared by withdrawing 1 mL of regular human insulin with a concentration of 100 units/mL and adding it to a sufficient quantity of 0.9% sodium chloride for injection in a polyvinylchloride bag to yield a total volume of 100 mL. The three admixtures were stored under refrigeration (2°C–8°C [36°F–46°F]), and one sample of each admixture was withdrawn and tested in duplicate at 0, 6, 24, 48, 72, 144, 168, 192, 216, 240, 312, and 336 hours. Utilizing high performance liquid chromatography, each sample underwent immediate testing. The time points were stable if the mean concentration of the samples exceeded 90% of the equilibrium concentration at 6 hours.
Results: The equilibrium concentration was 0.89 units/mL. Time points were stable if the mean concentration was at least 0.80 units/mL. All time points retained at least 90% of the equilibrium concentration, with the exception of hour 168 (0.79 ± 0.03 units/mL). At 192 hours the mean concentration was 0.88 ± 0.03 units/mL. At 336 hours the mean concentration was 0.91 ± 0.02 units/mL.
Conclusion: Based on these results, regular human insulin 100 units added to 0.9% sodium chloride for injection in a polyvinylchloride bag to yield a total volume of 100 mL is stable for up to 336 hours when stored at 2°C–8°C (36°F–46°F).

Keywords: insulin, stability, storage, temperature, USP 797, sodium chloride, polyvinylchloride

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