Ultra-High Speed Analysis of USP Methods Conforming to Permissible Limits in New USP General Chapter 621

In the General Chapter <621> Chromatography of the U.S. Pharmacopeia (USP), the ranges within which changes to HPLC and GC parameters are permissible are indicated, and as long as the values are within that range, and as long as the system suitability requirements are satisfied, the method can be changed without revalidation. The General Chapter 621 was again revised, and the revision has been in effect as of August 1, 2014.
According to the new revisions to the General Chapter 621, the column particle size can be freely selected. Here, we introduce an example of a faster analysis of a USP method in compliance with the new General Chapter 621 using the Nexera X2 ultra high performance liquid chromatograph and the Shim-pack XR-ODS III high-speed analytical column.