NMR line‐fitting quantification of polysaccharide N‐acylurea‐based modification in glycoconjugates of Salmonella Typhi Vi polysaccharide

The polysaccharides modification via carbodiimide reaction is one of the most applied methods for obtaining conjugated vaccines against Salmonella enterica. However, N‐acylurea carbodiimide adduct generated in the process is a critical impurity in carbohydrate‐based vaccines. A quantitative NMR method was developed for assessing the N‐acylurea carbodiimide adduct impurity. The procedure was based on line‐fitting facilities for processing the NMR signals on complex spectra. The method showed good linearity, accuracy and precision under inter‐operator variation (relative standard deviation <5%). Copyright © 2017 John Wiley & Sons, Ltd.