WP-092
USP monograph modernization initiative leading to modern ion chromatography-based methods
Summary
The United States Pharmacopeia (USP) and Food and Drug Administration (FDA) initiated a global effort in 2010 to update several monographs and General Chapters. The main reasoning behind this was to ensure their usefulness for the pharmaceutical industry at large along with integrating more modern analytical technologies by replacing non-specific tests.
Ion chromatography (IC) has greatly impacted pharmaceutical and biopharmaceutical analysis, effectively addressing limitations encountered with high-performance liquid chromatography (HPLC). The ability to separate ions, metals, polar molecules, and even non-ionic polar compounds offers IC users unique advantages. With IC, there is no need for special waste handling, and access to multiple detection options significantly widens the field of suitable applications.
The USP and FDA's modernization initiative has led to the development of IC-focused USP monographs and General Chapters. The versatility, selectivity, and sensitivity of IC make it an invaluable tool in the development of safe and effective pharmaceutical products. Its widespread acceptance and utilization in USP procedures reinforce its position as a vital analytical technique in the pharmaceutical industry.
Download white paper
This free white paper gives an overview of the USP modernization initiative and why ion chromatography has been adopted by USP on a large scale. In addition, it explains what ion chromatography is and how it overcomes limitations encountered with HPLC.
