DOI: 10.56530/lcgc.int.da7367z2 ISSN: 2996-9077

A Well-Written Analytical Procedure for Regulated HPLC Testing

Michael W. Dong

This paper describes the content of a well-written analytical procedure for regulated high-performance liquid chromatography (HPLC) testing. A stability-indicating HPLC assay for a drug product illustrates the required components for regulatory compliance, including additional parameters to expedite a laboratory analyst’s execution.

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