USP General Chapters <761> and <1761> are currently being revised by an Expert Panel. Since the last revision in 2013, there has been a surge in the utilization of NMR as a quantitative tool to determine the purity of organic compounds and the composition of mixtures. There is an urgent need to provide better guidance on the use of quantitative NMR (qNMR) for applications within the scope of USP.

The purpose of this presentation is to propose the adoption of qNMR as a measurement method that is consistent with the established principles and guidance framework of metrology—the science of measurement and its application.

New concepts, such as analytical target profile (ATP) and target measurement uncertainty (TMU) are introduced as the principal benchmarks to be used for validation of analytical procedures based on qNMR.

This on-demand recording is from USP’s qNMR Workshop, held November 17–19, 2020, and features presentations by Dr. Dan Sorensen and Dr. Christina Szabo.

Subject area:
Drug Products & APIs

Objectives (If applicable):
N/A

Target Audience (If applicable):
Analytical chemists
QC staff
QA staff
R&D staff
Regulatory staff