Validation of a Method of Measuring Mean Molecular Weight of Dextrans by Diffusion-Ordered Spectroscopy

Abstract

Amethod for measuring the mean molecular weight of dextrans by diffusion-ordered NMR spectroscopy was developed and validated. This method allows measurements of dextran self-diffusion coefficients to determine their mean molecular weight. The linearity, correctness, similarity, intralaboratory precision, and specificity of the method were evaluated. “Added/found” ratios for different dextrans were used to determine the standard deviations, coefficients of variation, significance intervals, systematic errors, Fisher’s F test, and Student’s t test for measurements of mean molecular weight. These statistical characteristics satisfied the criteria for validation parameters in the Russian and foreign normative documentation.