Type of Posting: Notice of Intent to Revise
Posting Date: 25-Sept-2024
Targeted Official Date: 01-Jun-2026, 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.
Chemical Analysis Expert Committee is canceling the PF 49(6) proposal and will publish an amended proposal in PF 51(2) with a targeted official date of June 1, 2026, to address comments received on the following sections. This upcoming revision will further clarify the use and applicability of the two sections.
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 and clarify the language further.
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, for the Organic Impurities test and Related Substances test, the requirement is waved if a determination of an %RSD is prescribed as part of the system suitability test.
This new PF proposal would require an additional step to align the official date for the two sections proposed for revision with the target official date of the PF 51(2) proposal, namely changing it from May 1, 2025, to June 1, 2026.
This would be implemented via a Revision Bulletin (RB) to be posted on November 22, and official on December 1, 2024. Below is the anticipated timeline for the changes described above:
- RB posted November 22, 2024 (New implementation date: June 1, 2026)
- RB Official December 1, 2024
- Proposed revision posted in PF 51(2) on March 3, 2025
- End of comment period May 31, 2025
- Ballot June 21, 2025
- Publication in USP-NF Nov 21, 2025
- Official June 1, 2026
If you have any questions or comments, please contact Edmond Biba, Senior Principal Scientist (exb@usp.org)