High Speed Analysis of Pharmaceutical Impurities in Compliance with European Pharmacopoeia Using Nexera-i MT

Introduction

In recent years, the development of short-time analytical methods for improving analytical task efficiency and productivity is promoting the uptake of an ultra-high- speed analytical technology that uses UHPLC systems and columns packed with microparticles in research and development departments in the pharmaceutical field. This trend also applies to pharmacopoeia. For example, according to "Adjustment of chromatographic condition"*1 described in the 8th edition of the European Pharmacopoeia (EP), adjustments to parameters in TLC, LC, GC and SFC are only allowed when the system suitability requirements are satisfied. In such a case, revalidation is not required. This article introduces an example of high speed analysis of pharmaceuticals and related substances in compliance with the EP using the Nexera-i MT integrated high performance liquid chromatograph.

April 27, 2017 GMT