| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 7630577 | Journal of Pharmaceutical and Biomedical Analysis | 2015 | 23 Pages |
Abstract
- PAC is the main drug substance in a commercial ophthalmic suspension.
- A C18 core-shell column has been used to develop a potency/impurities assay.
- This method replaces and outperforms the industry standard USP assay for potency.
- The developed method permits quantitation of all known impurities/degradants.
- The method was fully validated according to ICH recommendations.
Keywords
Related Topics
Physical Sciences and Engineering
Chemistry
Analytical Chemistry
Authors
Adrian Marley, Apryll M. Stalcup, Damian Connolly,