The US Pharmacopeial Convention (USP) solicited public comments on the draft revision of USP General Chapter <761> Nuclear Magnetic Resonance Spectroscopy published on USP-PF on July 1, 2022. In this webinar, Mr. Toru Miura, a member of the USP expert panel, introduced the content of the draft revision in detail, focusing on the updated content in the draft revision of USP General Chapter <761>. The following key issues were discussed: qNMR instrument qualification; calculation of measurement uncertainty; establish metrological traceability, and the implementation of qNMR analysis method validation using the concept of analytical method life cycle.

Subject area:
Drug Products & APIs

Objectives (If applicable):
N/A

Target Audience (If applicable):
Analytical scientist
QA/QC analysts
R&D staff
Regulatory staff
Contract research organizations
Contract manufacturing organizations