Manufacturing processes such as Solid Phase Peptide Synthesis (SPPS) used for chemically synthesizing peptide drugs can result in process and product related impurities that require characterization to ensure product quality and patient safety.
Currently, many assays for impurity assessment are HPLC-based with UV detection alone. Accurate assessment of impurities based on ICH Q3 guidelines using legacy methods can be challenging in the absence of established processing methods. The FDA encourages the incorporation of new technology for deeper product understanding and improved product quality.
MS technology has increasingly been deployed in analyses throughout the drug development process. As an orthogonal technique, mass detection increases the specificity of analytes providing a higher level of confidence for impurity analysis.
In this study we will demonstrate the incorporation of an in-line MS detector along with the Chromatography Data Software (CDS) Empower to strengthen analysis and reduce user-induced pitfalls in impurity analysis of synthetic peptides.