USP informs about Monographs affected by the Revision of NMR Chapters <761> and <1761>

Recommendation
7/8 October 2025
Performance Evaluation and Monitoring for compliant Analytical Procedures and Processes
In September 2023, we reported that proposed revisions to USP Chapters <761> and <1761> on Nuclear Magnetic Resonance Spectroscopy were published in Pharmacopeial Forum PF 49(5). Both chapters are scheduled to become official on 01 December 2025.
On 30 May 2025, USP published two Notices of Intent to Revise:
- Monographs Affected by Revision to <761> Nuclear Magnetic Resonance Spectroscopy
- Monographs Affected by Revision to <1761> Nuclear Magnetic Resonance Spectroscopy—Theory and Practice
According to these notices, the USP has identified other documentary standards that reference these General Chapters and are affected by the revisions proposed in PF 49(5). These references were updated on 02 June 2025 and are scheduled to become official on 01 December 2025.
The affected monographs are listed in two Excel files, which are available via the links provided in the respective notices.
USP encourages interested stakeholders to inform USP staff of any potential impact they may identify in connection with the planned updates.
Related GMP News
27.08.2025FDA Warning Letter: Missing Identity Tests, Unverified CoAs, and Inadequate DEG/EG Controls
20.08.2025USP Responds to Comments on Chapter <202> HPTLC Identification of Fixed Oils
13.08.2025USP publishes Comments rereived on Chapter <317>
13.08.2025FDA Issues Warning Letter to Contract Testing Laboratory for Inadequate OOS Investigations
06.08.2025EMA publishes Overview of Comments received on ICH M13B Guideline on Bioequivalence
06.08.2025FDA Warning Letter: Company Voluntarily Ceases Drug Production