Proposed revisions to USP <761> and <1761> and Applications of NMR to Pharmaceutical Drug Products

Description:
This presentation will cover the proposed major revisions to the USP General Chapters on NMR. The purpose of these revisions is primarily to modernize and expand NMR to better reflect its growing use in pharmaceutical analysis, define consistent NMR terminology, and establish quantitative NMR as a metrological method. Various applications of NMR relevant to pharmaceutical drug products will also be presented including the qualification of reference standards and use of NMR to determine relative response factors in the absence of standards. Perspectives of benchtop NMR will also be discussed.

Speaker: Christina Szabo - Baxter International
Dr. Christina Szabo is an Associate Director at Baxter Healthcare where she leads R&D Chemistry and Stability for the Renal Care business. Prior to that she was Director of Advanced Chemistry and Investigations in the Corporate Analytical Center of Excellence that supported all of Baxter’s businesses by application of Nuclear Magnetic Resonance, Mass Spectrometry, Extractables and Leachables, and Elemental Impurities. Her research started in natural products at University of Hawaiʻi, where she isolated compounds and elucidated structures of bioactive compounds in marine organisms. During her graduate studies at University of Illinois at Urbana-Champaign she probed relationships between protein conformations and NMR properties using quantum chemistry and experimental NMR. This led to computational studies in rational drug design and quantitative structure activity relationships. Since 2020, she has been serving on the USP Expert Panel for qNMR.