USP Monograph Modernization: Chemical Medicines Assay by Potentiometric Titration
28 Nov 2018
USP and Metrohm jointly developed a potentiometric titration method for potassium bicarbonate and potassium carbonate assay. The new method uses autotitration combined with suitable equivalence point detection fulfilling all USP method validation requirements as per USP General Chapter < 1225 >.
Many of the chemical medicine assay procedures are done by manual titration as per USP monographs. The manual titration procedure lacks data integrity and is prone to human error.
The new method developed in a collaboration between USP and Metrohm addresses these shortcomings. It utilizes autotitration combined with suitable equivalence point detection. Users benefit from more convenience, better reliability, and increased specificity. For high throughput needs, the new method can be easily automated.
However, autotitration combined with appropriate equivalence point detection methods not only eliminates manual errors but fulfills data integrity and 21 CFR Part 11 requirements, which makes the pharmaceutical QA/QC workflow easier. The new method offers selectivity and fulfills all USP method validation requirements as per USP General Chapter < 1225>.
