System Suitability for USP Methods - USP's Future Expectations

Recommendation

12-14 December 2023

Stability by Design - Live Online Training
- Stability Testing in Product Design and Method Development- Focus mainly on small-molecule APIs and drug products

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