In the Pharmacopeial Forum, PF 48(4), revisions of USP chapters <761> Nuclear Magnetic Resonance Spectroscopy and <1761> Applications of Nuclear Magnetic Resonance Spectroscopy are being proposed. Comments can be submitted until September 30, 2022.
According to the briefing notes, the revision of the two chapters has three main 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) explain essential concepts that underlie advanced methodologies for both qualitative and quantitative NMR analysis."
<761> Nuclear Magnetic Resonance Spectroscopy
The proposal for the revised Chapter <761> is structured as follows:
Qualification of NMR instruments - User Requirements Specification (URS) - Design Qualification (DQ) - Installation Qualification (IQ) - Operational Qualification (OQ) - Performance Qualification (PQ) - System Suitability Test (SST) - Qualification Test Procedures
Validation and verification of NMR analytical procedures - Analytical Procedure Validation with Life Cycle Approach - Analytical Procedure Validation with Traditional Approach - Analytical Procedure Verification
Compared to the currently valid version of the chapter (official as of May 1, 2018), the following changes, among others, were made:
The life cycle approach to analytical procedure validation is introduced.
The elements of qualification of NMR instruments are expanded. URS, DQ, and SST are included.
The chapter on qualitative and quantitative NMR analysis was revised.
An updated terminology framework was added.
<1761> Applications of Nuclear Magnetic Resonance Spectroscopy
First of all, it is proposed to change the title of the chapter to align with the other suite of spectroscopy chapters. The new title, "Nuclear Magnetic Resonance Spectroscopy—Theory and practice", also reflects the revised content within the chapter.
The revised Chapter <1761> is structured as follows: