Editors' Series: A Generic HPLC-UV Platform Method for Cleaning Verification
Wednesday, June 26, 2013
11:00 AM EDT
Editors’ Series: A Generic HPLC-UV Platform Method for Cleaning Verification
We describe the development and qualification of a simple, 10-min generic HPLC-UV gradient method for quantitative assays of cleaning verification solutions (0.2 – 10 mg/mL) and demonstrate approaches to increase sensitivity to low ng/mL levels by large-volume injections, sample concentrations, and the use of long-path UV flow cells. We report the attainment of similar method performance with a run time of 1.5 min using sub-2-μm or sub-3-μm core–shell columns on ultrahigh-pressure LC (UHPLC) systems. We provide rationales for parameter selections during the method development process to illustrate how the application of modern chromatographic principles can be used to quickly optimize method performance for intended use. This generic analytical methodology is readily adaptable to rinse or swabbing solutions and potentially for other applications such as in-process (IPC) control testing or rapid potency assays of many pharmaceuticals.
Sponsored by: Shimadzu
Troubleshooting Everywhere! An Assortment of Topics from Pittcon 2025
April 5th 2025In this installment of “LC Troubleshooting,” Dwight Stoll touches on highlights from Pittcon 2025 talks, as well as troubleshooting advice distilled from a lifetime of work in separation science by LCGC Award winner Christopher Pohl.
This information is supplementary to the article “Accelerating Monoclonal Antibody Quality Control: The Role of LC–MS in Upstream Bioprocessing”, which was published in the May 2025 issue of Current Trends in Mass Spectrometry.