The purpose of this study isto establish a new quality evaluation method of polymer-drugs using thehigh-resolution NMR spectroscopy. We focused on NMR profiling as the mostsuitable tool for rigorous quality evaluation because this approach can providestructural information on all molecules composing, and can distinguishstructural differences. Although it is thoughtthat the biological effect of polymer-drugs is influenced by the difference ofthe high-order structure of their molecules, it is difficult to evaluate adifference of the high-order structure by a conventional analytical method. Herein,we demonstrated that 1H NMR spectroscopy coupled with principal componentanalysis could precisely characterize the change of a profile in three kinds ofinsulin having different amino acid variation, human, bovine and porcineinsulins. The results suggest that this new methodology can be useful for thequality evaluation of biological polymer-drugs.

New approach for quality evaluation for
insulins derived from different species using <sup>1</sup>H NMR coupled with multivariate
analysis

242nd National Meeting (2011)

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New approach for quality evaluation for insulins derived from different species using 1H NMR coupled with multivariate analysis

New approach for quality evaluation for insulins derived from different species using ¹H NMR coupled with multivariate analysis