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High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry
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Is HPLC assay for drug substance a useful quality control attribute?

Jeffrey D Hofer1, Bernard A Olsen, Eugene C Rickard

  • 1Analytical Sciences Research & Development, Eli Lilly & Company, Lilly Corporate Center, Indianapolis, IN 46285, USA.

Journal of Pharmaceutical and Biomedical Analysis
|June 2, 2007
PubMed
Summary

High-performance liquid chromatography (HPLC) assay variability challenges drug substance quality control. A mass balance approach offers superior precision for process monitoring and stability studies, reducing false out-of-specification results.

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