BRIEFING
〈761〉 Nuclear Magnetic Resonance Spectroscopy. This proposal is based on the version of the chapter official as of May 1, 2018. On the basis of comments received, the previous proposal that appeared in PF 48(4) [July–Aug. 2022] has been canceled and replaced with this new proposal. Nuclear magnetic resonance (NMR) spectroscopy is an analytical method that uses the electromagnetic properties of nuclei placed in a magnetic field to characterize molecules qualitatively and quantitatively. A proposal to revise Applications of Nuclear Magnetic Resonance Spectroscopy 〈1761〉 also appears in this issue of PF. 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.
A summary of the major revisions to this chapter is as follows:
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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.
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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.
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Update instrument qualification tests and establish acceptance criteria for intended use and application.
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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.
Additionally, minor editorial changes have been made to update the chapter to current USP style.
(GCCA: Y. Liu)
Correspondence Number—C322477