| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 7630594 | Journal of Pharmaceutical and Biomedical Analysis | 2014 | 8 Pages |
Abstract
- There were performance issues with the USP HPLC method for amiodarone impurities.
- The USP method was successfully optimized using QbD approach.
- The method was successfully validated per ICH Q2R.
- The optimized method is equivalent to the USP method.
- The method is routinely used for determining amiodarone impurities.
Related Topics
Physical Sciences and Engineering
Chemistry
Analytical Chemistry
Authors
S. Karmarkar, X. Yang, R. Garber, A. Szajkovics, M. Koberda,