New Proposals for Revision of USP Chapters <761> and <1761> on NMR Spectroscopy Published for Comments

In the Pharmacopeial Forum, PF 49(5), revisions of USP chapters <761> Nuclear Magnetic Resonance Spectroscopy and <1761> Applications of Nuclear Magnetic Resonance Spectroscopy are being proposed. Based on the comments received, the previous proposals published in PF 48(4) have been canceled (please see our news archive for further information).

It is mentioned that "the proposed revisions to both chapters serve three primary purposes:

  • 1) to update the content with modern technologies and contemporary practices of NMR spectroscopy;
  • 2) to expand coverage of quantitative NMR (qNMR) applications to better reflect the established utility and growing use of qNMR in pharmaceutical analysis and metrology; and
  • 3) to explain essential concepts that underlie advanced methodologies for both qualitative and quantitative NMR analyses."

The two draft chapters are available on PF Online via the USP Website Access Point. The comments period runs from 01 September to 30 November 2023.

Chapter <761> Nuclear Magnetic Resonance Spectroscopy

The new proposal is based on the version of the chapter official as of 01 May 2018. In the briefing notes, the major revisions of chapter <761> are summarized as follows:

  • "1. Introduce the life cycle approach to analytical procedure validation, aligned with Analytical Procedure Life Cycle <1220>, which contains concepts such as analytical target profile and target measurement uncertainty.
  • 2. Expand the elements of qualification of NMR instruments beyond installation qualification, operational qualification, and performance qualification to include user requirements specifications, design qualification, and system suitability testing.
  • 3. Update instrument qualification tests and establish acceptance criteria for intended use and application.
  • 4. Revise the Qualitative and Quantitative NMR Analysis section by updating procedure requirements and providing additional details on sample preparation, certified reference material selection, acquisition parameters, and post-acquisition data analysis."

Chapter <1761> Applications of Nuclear Magnetic Resonance Spectroscopy

This proposal is based on the version of the chapter official as of 01 May 2013.

The briefing notes mention that the chapter was revised to align with the other suite of spectroscopy chapters and reflect the revised content within the chapter.

The following subchapters were added:

  • Characteristics of the NMR Spectrum
  • Acquisition Parameters
  • Other Experimental Considerations
  • Benchtop NMR

Some other parts were expanded. The section on solid-state NMR spectroscopy was removed, because a new general information chapter on the subject is being proposed.

Go back

GMP Conferences by Topics