LC-UV-Based Synthetic Peptide Impurity Tracking and Reporting with Compliant-Ready Empower 3 Software

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Brooke M. Koshel, Robert E. Birdsall, and Ying Qing Yu
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In this work, a UPLC-UV-based method is used for determining product purity using Empower 3 Chromatography Data Software (CDS).

This work demonstrates how Empower 3 Software can be easily employed for synthetic peptide impurity tracking in a compliant-ready workflow. Eledoisin was used as a model peptide to demonstrate how acceptance criteria can be used to assess reference sample material and a sample solution. Sample material was identified as having an impurity above the maximum allowed value for individual impurities to demonstrate failure to meet acceptance criteria. Empower reporting can then be used to retrieve and report data. In summary, this work demonstrates how Empower 3 Software offers integrated functionality for processing and reporting synthetic peptide data, thus enabling the assessment of product quality in an efficient, accurate, and compliant-ready manner.

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