Nexera XS inert
Measurement of Oligonucleotide Impurities Using Shimadzu Nexera XS Inert Coupled To LCMS-9030 QTOF
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User Benefits
- End-to-end workflow of oligonucleotide characterization using Shimadzu Nexera XS Inert, LCMS-9030 QTOF and LabSolutions Insight ™ Biologics software. - LabSolutions Insight Biologics software provides complete characterization of oligonucleotide main products and impurities.
Introduction
The biopharmaceutical industry is experiencing significant growth in the market for oligonucleotide therapeutics, such as antisense oligonucleotides and small interfering RNA (siRNA). To effectively characterize these oligonucleotides, High-Resolution Mass Spectrometry (HRMS) plays a crucial role in ensuring their quality, safety, and efficacy. Typically, impurities in oligonucleotides can arise from several factors, which include incomplete synthesis, degradation, or chemical modifications during the manufacturing process. Therefore, regulatory guidelines mandate the analysis of oligonucleotide impurities to evaluate product quality and ensure its compliance with regulatory standards.
This application note presents an end-to-end workflow for quantifying oligonucleotide impurities by spiking the oligonucleotides into a Full-Length Product (FLP). To ensure complete inertness of the sample flow path for optimal chromatographic separation, Nexera XS inert UHPLC system is used along with bioinert-coating metal-free Shim-pack™ Scepter Claris C18-300 column.
- Keywords: Oligonucleotide, High-Resolution Mass Spectrometry (HRMS), LabSolutions Insight Biologics, Nexera XS Inert, LCMS-9030 QTOF, Shim-pack Scepter Claris, LCMS
7 de noviembre de 2024 GMT
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