Further Modifications to USP Chapter <621> Chromatography Published for Comment

In the Pharmacopeial Forum, PF 51(2), a new version of USP General Chapter <621> Chromatography has been published for public comment.

As previously announced in a Notice of Intent to Revise in September 2024, the System Sensitivity and Peak Symmetry subsections have been further modified to clarify the application of these new requirements.

According to the briefing notes, 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."

The new draft of Chapter <621> Chromatography can be viewed on the Pharmacopeial Forum website. The commenting period is open until 31 May 2025.