BRIEFING

 〈621〉 Chromatography. This proposal is based on the version of the chapter official as of October 1, 2023. On the basis of comments received from stakeholders, the Chemical Analysis Expert Committee considered it appropriate to introduce modifications to the subsections System Sensitivity and Peak Symmetry. USP received comments and requests for clarification regarding the application of the chapter's new System Sensitivity and Peak Symmetry requirements to existing monographs. In some cases, data showed that the requirements cannot be fulfilled with the current official procedure given in the monograph. With the intention of clarifying the application of the new standard, the Chemical Analysis Expert Committee is proposing the following amendments to these two sections:

 System Sensitivity: The proposed text indicates that the requirement is applicable to impurity tests only when a reporting threshold is stated in the procedure in the individual monograph.

 Peak Symmetry: The proposed text indicates that this requirement is only applicable to Organic Impurities tests, Related Substances tests, and Assays. The text also clarifies that the requirement refers to the peak in the standard solution used for quantitation and that the requirement is waived if a determination of a percentage relative standard deviation is prescribed in the System Suitability test.

 Additionally, minor editorial changes have been made to update the chapter to current USP style.

 (GCCA: H. Pappa)

 Correspondence Number—C325226