A Well-Written Analytical Procedure for Regulated HPLC Testing
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.
Authors
- Michael W. Dong
Publication Details
- Journal
- LCGC International
- Published
- 2024-10-01
- DOI
- https://doi.org/10.56530/lcgc.int.da7367z2
- Citations
- 1
- Primary Topic
- Analytical Chemistry and Chromatography
- Type
- article
- Field-Weighted Citation Impact
- 0.24