LCGC North America-06-01-2020

Click the title above to open the LCGC North America June 2020 issue, Volume 38, Number 6, in an interactive PDF format.

When you restart liquid chromatography (LC) instrumentation that was idle during the COVID-19 shutdown, you need to follow a systematic approach. Otherwise, problems may appear in days or weeks following startup.

Determining product shelf life is a regulatory requirement for pharmaceuticals and many other regulated consumer products. In this comprehensive overview of stability studies and testing, we summarize current regulatory requirements, share industry practices for forced degradation, and explain approaches for reduced testing and data evaluation to expedite stability study timelines.

Multidimensional separations, in which two or more separation methods are coupled, are a valuable analytical tool for higher peak capacity and improved selectivity for the analysis of complex samples like biotherapeutics.

There are many potential causes of reduced peak size in gas chromatography (GC), and an inexperienced GC user may not know where to begin the troubleshooting process. Here, we review potential causes for reduced peak size in GC systems.

Chromatography data systems (CDS) have been at the center of multiple FDA 483 citations and warning letters, with an emphasis on peak integration and interpretation of chromatograms. Here, we review the issues associated with ensuring compliance when performing peak integration.