USP Monograph Modernization Initiative: Chemical Medicines Assay by Potentiometric Titration

This poster presented jointly with USP at AAPS meeting shows the new potentiometric titration assay method for potassium bicarbonate and potassium carbonate assay which offers selectivity and fulfills all USP method validation requirements as per USP General Chapter < 1225>. Potentiometric titration based assay determination is faster and easy to use compared to the chromatographic techniques and can be easily automated to fulfill high throughput needs. Autotitration combined with appropriate equivalence point detection methods not only eliminates manual errors, but fulfills data integrity and 21 CFR 11 requirements, which makes the pharmaceutical QA/QC workflow easier.