LCGC North America-06-01-2020

LCGC North America

Vol 38 No 6 LCGC North America June 2020 Regular Issue PDF

June 01, 2020

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

Stability Studies and Testing of Pharmaceuticals: An Overview

June 01, 2020

Perspectives in Modern HPLC

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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 Separation Techniques for Characterization of Biotherapeutics

June 01, 2020

Focus On Biopharmaceutical Analysis

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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.

Troubleshooting Gas Chromatography: Reduced Peak Size (Loss of Sensitivity)

June 01, 2020

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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.

Are You Controlling Peak Integration to Ensure Data Integrity?

June 01, 2020

Feature Article

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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.