System Suitability for USP Chromatographic Methods

Recommendation

27/28 November 2019
Barcelona, Spain

Setting Specifications and Acceptance Criteria

An interesting article from the USP experts group "Small Molecules" has been published in the Pharmacopoeial Forum 39(5). It deals with USP's future requirements regarding system suitability tests (SST).

SSTs are performed each time an analytical method is used. Together with instruments qualification and methods validation, the SST ensures the quality of analytical test results. The SST shows that a procedure and an instrumental system are performing as they did when the procedure was validated and that the method is thus "fit for purpose" for the intended use.

General requirements can be found in the USP Chapter <621> Chromatography which also contains provisions and acceptance criteria for individual parameters of the SST. Nevertheless, parameters and acceptance criteria laid down in specific monographs always take priority over the general provisions provided in General Chapter <621>.

In the article, the USP Expert Committee has noted that because of many different sponsors who have submitted a number of various monographs to the USP, inconsistencies with regard to SSTs in the USP have arisen.

That's why the USP Expert Committee has described in this article which data are required on SSTs for new monographs or monographs to be updated. The following descriptions are provided:

• Assay
• Impurities
• Dissolution
• Content Uniformity 

 You can find all information on the USP website of the Pharmacopeial Forums (PF).

Source: USP