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Ion chromatography for the pharmaceutical industry

Nov 18, 2024

Article

Ion chromatography (IC) is an analytical technique used to separate and quantify ionic and polar analytes. IC has become widely accepted by the pharma industry and regulatory bodies for an expanded range of applications like water quality and chemical analysis. It has qualified in recent years to analyze pharmaceuticals. The United States Pharmacopeia-National Formulary (USP-NF, US Pharmacopeia (USP)), the driving standardization body for (bio)pharmaceutical products, increased IC's potential during their modernization approaches, establishing it as an appropriate and valid technique in their compendial General Chapters, assays, and impurity tests.

This article briefly introduces the principles of ion chromatography, then discusses applications and benefits of using it for pharmaceutical analysis on the basis of USP General Chapter <1065> Ion Chromatography.

What is ion chromatography?

Ion chromatography is a type of high-performance liquid chromatography (HPLC) used to separate and quantify ionic and polar analytes simultaneously, most often using ion-exchange as the separation mechanism [13] (Animation 1).