Technical note: System precision in HPLC analysis of APIs and impurities
Posted: 22 December 2021 | Thermo Fisher Scientific | No comments yet
HPLC users expect robust, reliable systems with equivalent performance and reproducibility between systems that greatly facilitates method transfer.
A global study of multiple Thermo Scientific™ Vanquish™ Core HPLC systems was conducted to demonstrate system to-system variability across different operators in different locations running the same application. It was shown that retention time reproducibility is largely influenced by eluent preparation and peak area reproducibility primarily depends on sample preparation. Regardless of where and by whom the HPLC system was operated, each system met the criteria set for system suitability.
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Analytical techniques, Biologics, Biopharmaceuticals, Chromatography, Data integrity, Excipients, Formulation, Informatics, Mass Spectrometry, Proteomics, QA/QC, Regulation & Legislation, Research & Development (R&D), Spectroscopy, Vaccines