NMR Spectroscopic Analysis to Evaluate the Quality of Insulin: Concentration, Variability, and Excipient Content. (January 2020)

• Record Type: Journal Article
• Authors: Malmodin, Daniel; Pedersen, Anders; Karlsson, B. Göran; Forsander, Gun
• Is Part Of: Journal of diabetes science and technology. Volume 14:Number 1(2020:Jan.)
• Page Start: 180
• Page End: 184
• Publication Date: 2020-01
• Subjects: type 1 diabetes -- insulin -- insulin treatment -- NMR -- children -- insulin sustainability; Diabetes -- Periodicals; Medical technology -- Periodicals; Diabetes Mellitus -- Periodicals; 616.462005
• DOI: 10.1177/1932296819831995
• Languages: English
• ISSNs: 1932-2968

Abstract

Known and consistent bioactivity between samples of insulin is essential to correctly estimate the dose. Insulin concentration is not the same thing as bioactivity, however, and methods to correctly determine both are required. Here we show that one dimensional nuclear magnetic resonance (1D NMR), in contrast to, for example, reverse phase high pressure liquid chromatography, can be used to determine both insulin concentration as well as confirm the structural integrity required for activity. In response to the report by Carter and Heinemann, we decided to investigate insulin intended for public use. Insulin from several manufacturers was investigated. Correct insulin concentrations were found in all tested samples although the general sample variability, which possibly could influence the bioactivity, varied depending on insulin type and manufacturer.