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LC-MS method development and method transfer for patisiran siRNA impurity analysis Be the first to rate this application

Description

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.
Market: BioPharma
Keywords: mass spectrometry, Method Development, siRNA, Quality control, oligonucleotide analysis, ion-pairing reversed-phase liquid chromatography, impurity identification, sample purity
Matrix: Water
Author: Denis Andrei Ispan
Affiliation: Thermo Fisher Scientific, Germering
Uploaded on 2/20/2024.