Allowable Changes to Chromatography Methods for HPLC – More Freedom for Chromatographers Granted by the Pharmacopeias?
February 03, 2023
The new General Chapter does reflect the great work of the Pharmacopoeias in helping chromatographers to use more modern technology for their regulated methods, speeding up analysis, and reducing waste. The latest revision allows us to adjust column dimensions for gradient separations, which is a significant advance. Although these freedoms are welcomed, one must be very mindful of the requirements or limits of the allowable changes and the verification work that underpins our demonstration of equivalent performance of the adjusted method.