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

Journal article
Authors Daniel Malmodin
Anders Pedersen
B Göran Karlsson
Gun Forsander
Published in Journal of diabetes science and technology
Pages 1-5
ISSN 1932-2968
Publication year 2019
Published at Swedish NMR Centre at Göteborg University
Institute of Clinical Sciences
Pages 1-5
Language en
Links dx.doi.org/10.1177/1932296819831995
www.ncbi.nlm.nih.gov/entrez/query.f...
Subject categories Biophysics, Structural Biology

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.

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