Commercially Available Insulin Products Demonstrate Stability Throughout the Cold Supply Chain Across the United States
Year: 2020
Type: other
Abstract: 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.
Authors: Timothy J. Garrett, Philip Atkinson, Eoin P. Quinlivan, Lynn Ang, Irl B. Hirsch, Lori Laffel, Massimo Pietropaolo, Michael J. Haller, Mark A. Atkinson
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: gold
OpenAlex ID: W4254325806