Application of General Chapter <1220> in the Development of Procedure for Quantitative NMR

Description:
Nuclear magnetic resonance (NMR) spectroscopy has historically been employed for structure elucidation; however recent advances in instrumentation and in data processing have prompted renewed interest in its quantitative applications. Quantitative NMR (qNMR) possesses numerous advantages, not least of them being its universality, and molar proportionality of response. With the recent advent of affordable permanent-magnet benchtop systems, qNMR now exhibits compelling potential in QC analysis. For analytical methods, AQbD can provide a systematic framework to achieve a continuously validated, robust assay as well as life cycle management. In the present study, it applied the life cycle approach to qNMR procedure validation, aligned with Analytical Procedure Life Cycle 〈1220〉, that contains concepts such as analytical target profile and target measurement uncertainty. In perspective, it is within the pharmacopoeia’s mission to work with appropriate parties to work toward a harmonized framework of physical and documentary standards.

Speaker: Yang Liu - U.S. Pharmacopeial Convention
Dr. Yang Liu is Scientific Liaison in USP’s General Chapters. Dr. Liu collaborates with scientific experts to advance qNMR applications into USP. Dr. Liu is working with the USP qNMR Expert Panel revising General Chapters <761> and <1761> and leading to build USP Education courses in qNMR. Dr. Liu leads research and development of qNMR-based digital products at USP. Dr. Liu is a guest scientist at the NIST, concentrating on the evaluation of benchtop NMR pharmacopeial applications. Dr. Liu has been invited by the ISO Working Group (ISO/TC 34/WG 24), to review the ISO qNMR standards. Dr. Liu’s scientific expertise includes qNMR method development and validation for measurement of individual molecules and natural products and qNMR-based quantum mechanics analysis. He has published over 20 peer-reviewed articles and has been an invited speaker or workshop organizer for numerous international scientific conferences.