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

Introduction

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. An example of a faster method by which these changes remained within the permissible range was previously introduced in Application News No. L448. The General Chapter 621 was again revised, and the revision has been in effect as of August 1, 2014. Previously, a reduction of up to 50 % in the column particle size was permitted, but according to the new revisions to the General Chapter 621 that has been in effect, the column particle size can be freely selected. Therefore, even though the current particle size of 5 μm is specified, columns with particle size in the sub-2 μm region may be used, permitting even faster analyses. 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 u l t r a high performance liquid chromatograph and the Shim-pack XR-ODS Ⅲ high-speed analytical column. *Shimadzu Scientific Instruments, Inc., USA

September 3, 2014 GMT