Development Of An Effective LC-MS/MS Cleaning Validation Method For Synthetic Peptide Drug Substances

By Bhaskar K., Tirumal Datar, Taposh Gorella, and Padmakar Wagh, Waters Corporation

This application note presents the development of a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method designed for the simultaneous, sensitive, and robust quantification of therapeutic peptides. The method aims to streamline analytical workflows while maintaining high accuracy and reliability, which are essential in pharmaceutical quality control. Ensuring the safety of drug products requires manufacturers to maintain strict oversight of their production processes. This includes the precise monitoring of the active pharmaceutical ingredient (API), as well as the detection and quantification of impurities and potential contaminants. Such contaminants often arise from cross-contamination during the manufacturing of different drug products on shared equipment. To mitigate this risk, comprehensive cleaning procedures are implemented after each manufacturing cycle.

Discover how these cleaning protocols are critical for preventing carryover of substances from previous batches to safeguard product integrity and patient safety. The LC-MS/MS method described here supports these efforts by providing a dependable analytical tool for detecting even trace levels of peptides and contaminants.