Insulin is a small polypeptide hormone that controls blood glucose homeostasis. Genetic engineering techniques have enabled biopharma companies to develop diverse, long-acting insulin analogs. There is no pharmacopeia method available for the analysis of insulin analogs. An SEC method identifying innovator and biosimilar insulin analog, following a draft EP method, was developed using an Agilent AdvanceBio SEC 130 Å, 7.8 × 300 mm, 2.7 μm column. The effectiveness of this method, for routine analysis, was confirmed using a system suitability test, and retention time (RT) and area precision studies using innovator insulin as a reference material. This Application Note also presents the application of this column for detecting impurities with molecular masses greater than that of insulin for quantitation studies.
Publication number: 5991-6872EN
Publication Date: May 1, 2016