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

Abstract

OBJECTIVE 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). 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 analog insulins measured by the USP methods (n = 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. CONCLUSIONS Insulin purchased from U.S. pharmacies is consistent with product labeling.