LC-MS method development and method transfer for patisiran siRNA impurity analysis
Instrument Type: UHPLC
A process for analyzing and identifying siRNA sequences and their production impurities using LC-HRAM-MS and BioPharma Finder software. The method was optimized for chromatographic separation of impurities and ISQ EM signal, and impurities were confirmed using Orbitrap Exploris 240 mass spectrometer and oligonucleotide sequencing analysis. The process is transferable to a quality control setting for routine analysis and generates a comprehensive report on sample purity for each primary component, including co-eluting impurities and their relative abundance.