Evaluation of lot-to-lot consistency in ion exchange chromatography

The reproducibility of ion exchange columns was investigated by rigorously evaluating critical chromatographic parameters as well as the performance o f these ion exchange columns under various modes of operation. A detailed s et of experiments were carried out to determine equilibrium Steric Mass Act ion 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 disp lacement chromatographic conditions. While differences between the two lots were observed with isocratic experiments, the columns exhibited similar be havior under gradient, frontal, and displacement conditions. Furthermore, s imulations obtained with the SMA model were shown to predict column perform ance under linear and non-linear conditions.