美国药典各论现代化倡议促成基于离子色谱的现代方法
WP-092
zh
USP 和 FDA 开始对多部各论和通则进行现代化。在许多情况下，以 离子色谱仪为重点的方法取代了旧式的湿化学程序。在本白皮书中，您将了解更多有关 USP 现代化计划和离子色谱法优势的信息。
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.
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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.