Application Note: USP Monograph Modernization Initiative: Chemical Medicines Assay by Potentiometric Titration
28 November 2018

Many of the chemical medicine assay procedures are done by manual titration as per USP monographs. The manual titration procedure lacks data integrity and adds another layer of complexity. Pharmaceutical QA/QC needs an analytical technique with data integrity for FDA audits and reliable product release. As science advances, the USP reviews monographs to assess if they should be changed to reflect recent innovations and technology updates making laboratory analysis more efficient, cost-effective, and safe. Autotitration combined with suitable equivalence point detection not only improves specificity, but fulfills data integrity. As part of USP monograph modernization, a new assay method for potassium bicarbonate and potassium carbonate is developed and validated using autotitration.