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Commercially Available Insulin Products Demonstrate Stability Throughout the Cold Supply Chain Across the United States

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posted on 09.04.2020 by Timothy J. Garrett, Philip Atkinson, Eoin P. Quinlivan, Lynn Ang, Irl B. Hirsch, Lori Laffel, Massimo Pietropaolo, Michael J. Haller, Mark A. Atkinson
Objective

A recent publication questioned the integrity of insulin purchased from U.S. retail pharmacies. We sought to independently validate the method employed, isotope dilution solid phase extraction (SPE) liquid chromatography (LC) mass spectrometry (MS) and expand analysis to two U.S. Pharmacopiea (USP) methods (high performance LC with ultra-violet detection (LC-UV) and LC-MS).

Research Design and Methods

Each method was used to evaluate nine insulin formulations, purchased at four pharmacies, within five geographic locations in the U.S.

Results

All human and analogue insulins measured by the USP methods (n=174) contained the expected quantity of active insulin (100±5 U/mL). When using isotope dilution SPE-LC-MS, U/mL values were well below product labeling due to unequal recovery of the internal standard compared to target insulin.

Conclusions

Insulin purchased from U.S. pharmacies is consistent with product labeling.

Funding

These studies were supported by the JDRF, American Diabetes Association, and The Leona M. and Harry B. Helmsley Charitable Trust. The funders were consulted regarding study design to determine the number of insulin products and pharmacies for analysis. However, the funding sources were not involved in the collection, analysis, and interpretation of the data, nor did they influence the writing of the report or the decision to submit the manuscript for publication.

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