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Understanding potentiometric titration: A vital technique in pharmaceutical analysis

Jan 20, 2025

Article

Quality control in the pharmaceutical industry is indispensable. As a selected test method, titration is described in many pharmacopeias due to its ease of performance and accuracy, as for example in the United States Pharmacopeia-National Formulary (USP-NF) General Chapter <541>. Here, potentiometric titration and other detection principles in an automated titration procedure exemplify a simplified approach compared to manual titration practices. This article details how to successfully switch from manual titration to automated titration in the pharmaceutical industry.

Applicability of modern titration methods in pharmaceutical analysis

General Chapter <541> Titrimetry describes the quantitative technique, focusing on the different types of titrations as well as the materials and equipment needed for the titration. The latest updated version of USP <541> now officially accepts automated titration as a modern titration method for pharmaceutical analysis. This General Chapter states that an automated titrator is a «multifunctional processing unit that is able to perform the steps of a titration» [1]. 

Compared to manual titration, automated potentiometric titration in pharmaceutical analysis improves on accuracy, precision, and efficiency. This is why Metrohm offers a variety of applications for several API monographs of the United States Pharmacopeia as well as pharmacopeia-compliant analytical instruments.

Learn more about the principles of titration in the blog post «Titration – definition and principles».