Type of Posting: Notice of Intent to Revise
Posting Date: 25-Aug-2023
Targeted Official Date: May 1, 2025, In-Process Revision
Expert Committee: General Chapters- Chemical Analysis (GCCA)
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Chemical Analysis Expert Committee intends to revise General Chapter <621> Chromatography.
Based on the comments received from stakeholders, the committee considered it appropriate to introduce a change in the text under the subsections System sensitivity and Peak Symmetry.
USP has been receiving comments and requests of clarification regarding the application of the new requirements in <621> of System sensitivity and Peak symmetry to existing monographs. In some cases, data showed that the requirements cannot be fulfilled with the current official procedure in the monograph. The GCCA-EC will propose an amendment to the text in these two sections with the intention of clarifying the application of the new standard.
System sensitivity: The text will indicate that the requirement is applicable to impurity tests only when a reporting threshold is stated in the procedure in the individual monograph.
Peak Symmetry: We will propose to introduce text indicating that this requirement is only applicable to Organic impurity, Related substances tests, and Assay. The text will also clarify that the requirement refers to the peak in the standard solution used for quantitation and that the requirement is waved if a determination of an %RSD is prescribed as part of the system suitability test.
It is anticipated that the proposed revision to General Chapter <621> will be published as an In-process revision in PF 49(6) with a targeted official date of May 1, 2025. This new PF proposal would require an additional step to align the official date for the two sections proposed to be revised with the target official date of the PF proposal, namely changing it from Dec 1, 2023 to May 1, 2025.
This would be implemented via a Revision Bulletin (RB) to be posted on September 29 and official October 1, 2023.
Below is the anticipated timeline for the changes described above:
- RB posted September 29 (New implementation day May 1, 2025)
- RB Official October 1, 2023
- Proposed revision posted in PF 49(6) on Nov 1, 2023
- End of comment period Jan 31, 2024
- Ballot June 21, 2024
- Publication in USP-NF Nov 1, 2024
- Official May 1, 2025
If you have additional questions, please contact Horacio Pappa (hp@usp.org).