Aggregate Analysis Of Insulin Analogues Using A Biozen dSEC-1 SEC Column

By Sujatha Chilakala, Ph.D., and Lucia Geis-Asteggiante, Ph.D.

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Insulin analogues, like native insulin, are therapeutic peptides essential for regulating blood glucose levels. However, both native insulin and its analogues can form aggregates during storage or in vivo, which may decrease absorption and uptake, making the assessment of purity crucial. Size Exclusion Chromatography (SEC) is the standard approach for determining high molecular weight (HMW) impurities in these products.

This technical note explores the challenging SEC analysis of HMW impurities in two specific insulin analogues: Insulin Glargine and Insulin Lispro. It evaluates the performance of Biozen dSEC-1 SEC columns under USP General Chapter <121.1> denaturing conditions, comparing two different column dimensions. See the full results to learn how both columns successfully separated the monomer and dimer peaks, providing excellent resolution and reproducibility.