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. 2018 Jul;12(4):839-841.
doi: 10.1177/1932296817747292. Epub 2017 Dec 21.

Insulin Concentration in Vials Randomly Purchased in Pharmacies in the United States: Considerable Loss in the Cold Supply Chain

Alan W Carter  1   2 , Lutz Heinemann  3
Affiliations

Insulin Concentration in Vials Randomly Purchased in Pharmacies in the United States: Considerable Loss in the Cold Supply Chain

Alan W Carter et al. J Diabetes Sci Technol. 2018 Jul.

Abstract

The insulin content in vials/cartridges should be 95 U/ml upon release. No independent confirmation of insulin concentration is available when purchased in the pharmacy (end of the cold supply chain). We quantitatively measured intact insulin in randomly acquired multidose human insulin vials by standard analytical methods. Eighteen 10 ml vials from two manufacturers (M1 and M2) were randomly acquired. The intact insulin concentration ranged from 13.9 to 94.2 U/ml, mean 40.2 U/ml. No vial met the minimum standard of 95 U/ml. These results imply the cold supply chain impacts insulin concentrations to a larger extent than anticipated. Patients are paying high prices for insulin and should expect to receive insulin vials with adequate insulin content in return.

Keywords: analysis; insulin; insulin content; quality assurance; vials.

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Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: AWC is employed by MRIGlobal as the pharmacist manager and principal investigator for NIH-NINDS and NCATS Drug Manufacturing Development Program contracts. LH is a consultant for a number of companies that develop novel diagnostic and therapeutic options for the treatment of patients with diabetes. He owns shares of the Profil Institut für Stoffwechselforschung, Neuss, Germany and ProSciento, San Diego, CA, USA.

Figures

Figure 1.
Figure 1.
Example overlay comparing the USP Insulin Standard intact insulin result to five sample lot intact insulin results using Waters Xevo G2-XS QTOF. All peaks were observed at 4.53 retention time and are offset on the x-axis to allow visualization of differences in concentrations found.
Figure 2.
Figure 2.
The 95 U/ml minimum outlined in red and the 95 U/ml threshold red line represent the smallest concentration of intact insulin allowed by the FDA for release by the manufacturer. N = 18, range = 13.9-94.2 U/ml, mean = 40.2 U/ml. To deidentify manufacturer source samples are labeled REGULAR M1 (a-d) and REGULAR M2 (a-e); NPH M1 (a-d) and NPH M2 (a-e).
See this image and copyright information in PMC

Comment in

References

    1. Carter AW, Heinemann L, Klonoff DC. Quality control of insulins and biosimilar insulins: what do we know? J Diabetes Sci Technol. 2016;10(4):811-815. - PMC - PubMed
    1. Chambers EE, Legido-Quigley C, Smith N, Fountain KJ. Development of a fast method for direct analysis of intact synthetic insulins in human plasma: the large peptide challenge. Bioanalysis. 2013;5(1):65-81. - PubMed
    1. Congress.gov. H.R.3204—Drug Quality and Security Act. Available at: https://www.congress.gov/bill/113th-congress/house-bill/3204. Accessed September 18, 2017.

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