EVALUATION OF LOT-TO-LOT CONSISTENCY IN ION EXCHANGE CHROMATOGRAPHY

Abstract

The reproducibility of ion exchange columns was investigated by rigorously evaluating critical chromatographic parameters as well as the performance of these ion exchange columns under various modes of operation. A detailed set of experiments were carried out to determine equilibrium Steric Mass Action parameters, HETP, column dead volume, total ion capacity, and porosity. In addition, the performance of these columns was examined under isocratic, analytical linear gradient, overloaded linear gradient, frontal, and displacement chromatographic conditions. While differences between the two lots were observed with isocratic experiments, the columns exhibited similar behavior under gradient, frontal, and displacement conditions. Furthermore, simulations obtained with the SMA model were shown to predict column performance under linear and non-linear conditions.