Using Compliant-Ready Software for Synthetic Peptide Impurity Tracking and Reporting with Added Mass Detection for Improved Confidence in Results

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Brooke M. Koshel, Ximo Zhang, Robert Birdsall, Joe Fredette, Scott Berger, and Asish Chakraborty
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Impurities that result from the synthetic peptide manufacturing process or from degradation during manufacturing or storage are typically assayed by HPLC, which can be susceptible to many user-induced pitfalls. In this study, eledoisin is used as a model analyte to demonstrate the automated processing and reporting of impurities within a compliant-ready software package, which reduces user error.  

By incorporating an orthogonal mass detection strategy, peaks that are out of specification can be readily interrogated, and product purity can be readily assessed for further method optimization. This strategy demonstrates the ability to improve confidence in results by combining optical detection and orthogonal mass detection into a single workflow while maintaining compliance.

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