Commercially Available Insulin Products Demonstrate Stability Throughout the Cold Supply Chain Across the U.S.

Abstract

A recent publication questioned the integrity of insulin purchased from U.S. retail pharmacies. We sought to independently validate the method used, isotope dilution solid-phase extraction (SPE) liquid chromatography mass spectrometry (LC-MS), and expand analysis to two U.S. Pharmacopeia (USP) methods (high-performance LC with ultraviolet detection and LC-MS). Each method was used to evaluate nine insulin formulations, purchased at four pharmacies, within five geographic locations in the U.S. All human and analog insulins measured by the USP methods (<i>n</i> = 174) contained the expected quantity of active insulin (100 ± 5 units/mL). When using isotope dilution SPE-LC-MS, units-per-milliliter values were well below product labeling due to unequal recovery of the internal standard compared with target insulin. Insulin purchased from U.S. pharmacies is consistent with product labeling.