LC-UV-Based Synthetic Peptide Impurity Tracking And Reporting With Compliant-Ready Empower 3 Software

By Brooke M. Koshel, Robert E. Birdsall, and Ying Qing Yu, Waters Corporation

This application note presents a UPLC-UV-based method for determining product purity using Empower 3 Chromatography Data Software (CDS). It highlights how Empower 3 Software can be effectively utilized for tracking impurities in synthetic peptides within a compliant-ready workflow. Using eledoisin as a model peptide, the study demonstrates how acceptance criteria can be applied to evaluate both reference sample material and sample solutions. In one case, the sample material was found to contain an impurity exceeding the maximum allowable limit for individual impurities, thereby failing to meet the acceptance criteria. Empower’s robust reporting capabilities were then used to retrieve and document the data.

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