BRIEFING

 〈621〉 Chromatography. This proposal is based on the version of the chapter official as of December 1, 2024. On the basis of comments received from stakeholders, the Chemical Analysis Expert Committee canceled the proposed revision published in PF 49(6) and has decided to further modify the System Sensitivity and Peak Symmetry subsections to clarify the applications of these new requirements.

 Therefore, 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. It also indicates how the test is performed and how the requirement is met.

• Peak Symmetry: The proposed text indicates that this requirement is only applicable to Organic Impurities and Related Substances tests and Assays. The text clarifies that the requirement refers to the peak in the standard solution used for quantitation. The text also clarifies that, for the Organic Impurities and Related Substances tests, 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: E. Biba)

 Case ID—SUB-1743