System Suitability for USP Methods - USP's Future Expectations
Recommendation
Tuesday, 4 February 2025 9 .00 - 17.00 h
Establishment, Use and Maintenance of Analytical Reference Substances
An interesting article from the USP experts group has been published in the Pharmacopoeial Forum 39(5). It deals with small molecules and describes the requirements regarding system suitability tests (SST) for chromatographic procedures submitted in new or revised monographs.
System suitability tests are performed each time a chromatographic method is used. They thus belong to the scientific working practices in the laboratory beside analytical instruments qualification, and methods validation.
For many years, general acceptance criteria for the SST have been described in USP General Chapter <621>. Nevertheless, parameters and acceptance criteria laid down in specific monographs always take priority over the general provisions provided in General Chapter <621>.
Because at the USP a wide range of proposals are submitted by different sponsors, this leads to apparent inconsistencies in chromatographic system suitability requirements for monographs. Moreover, many SST requirements are now obsolete and no longer the state of the art.
The article thus describes the future expectations regarding the parameters and acceptance criteria for both HPLC and GC methods. The following tests are listed:
- Assay
- Impurities
- Dissolution and Content Uniformity.
You can find all information on the USP website of the Pharmacopeial Forums (PF).
Source: USP - http://www.usp.org
Related GMP News
16.10.2024US FDA Warning Letter: Lab Data Integrity issues
16.10.2024FDA Warning Letter: Component Testing, Validation, and Stability
16.10.2024EDQM publishes New Chapter "Quality of Data" for Comments
16.10.2024USP Chapter <621> Chromatography: Notice of Intent to Revise
15.10.2024Pharmeuropa Text for Comment: HPTLC for Herbal Products
09.10.2024WHO Biowaiver Project Cycle VII (2025) and Results from Cycle VI (2024)