The Growing Regulatory Burden and Revolution in Global Clinical Trials

During a recent LCGC International peer exchange discussion on nitrosamine analysis, our professional panelists discussed the complex issues surrounding the processes for detecting nitrosamines.

LCGC International spoke with Daniel Meston and Dwight Stoll from Gustavus Adolphus College in St. Peter, Minnesota, USA, about a project they worked on with Todd Maloney from Eli Lilly in Indianapolis, Indiana, USA, to investigate the optimal performance conditions of antisense oligonucleotides (ASOs) when using hydrophilic interaction liquid chromatography (HILIC).

This article discusses several practical examples using bioinert columns, demonstrating their ability to deliver reliable, high-resolution results with precision and reproducibility.

A new method has been created for determining N-nitrosamines (NAs) in pharmaceutical preparations using liquid chromatography with tandem mass spectrometry.

A research group has developed an improved workflow for constructing machine learning (ML) models in oligonucleotide separation.

Supercritical fluid chromatography (SFC) has been optimized for the analysis of 5-, 10-, 15-, and 18-mer oligonucleotides (ONs) and evaluated for its effectiveness in separating impurities from ONs.