USP General Chapter <621> Chromatography: Delay of the Implementation of Two New Requirements
Recommendation

Monday, 21 September 2026 14.00 - 16.00 h
Regulatory Landscape: ECHA, USP, Pharmacopoeias and FDA Enforcement
The revised USP General Chapter <621> Chromatography is scheduled to be official on 01 December 2022. The Chemical Analysis Expert Committee has now announced that the implementation of the sections titled "Peak Sensitivity" and "Peak Symmetry" under "System Suitability" will be delayed.
In a Notice of Intent to Revise posted on 26 August 2022, it is stated that, based on the comments received, the committee considered that stakeholders may need additional time to evaluate the impact of these two new requirements.
It is intended that the proposed revision to General Chapter <621> will be published as a Revision Bulletin on 28 October 2022. The Chemical Analysis Expert Committee expects "that during the extended period of implementation stakeholders will evaluate existing compendial procedures and submit comments."
More Information is available on the USP-NF Website.
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