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.