This course covers General Chapters <761> and <1761>, highlighting key advancements in Nuclear Magnetic Resonance Spectroscopy (NMR) and quantitative NMR (qNMR) methodologies.
– General Chapter <761> updates key aspects in qNMR analysis, such as instrument qualification, uncertainty measurement, and application of analytical procedure lifecycle approach in qNMR analytical method validation. It also revises procedure requirements, providing additional details on sample preparation, certified reference material selection, acquisition parameters, and post-acquisition data analysis.
– General Chapter <1761> includes basic theoretical principles, instrumentation, and general experimental considerations, and updates modern technologies and contemporary practices of NMR spectroscopy, qNMR applications to better reflect the established utility and growing use of qNMR in pharmaceutical analysis and metrology; and essential concepts that underlie advanced methodologies for both qualitative and quantitative NMR analyses.
Accordingly, this course serves stakeholders who are interested in NMR best practice for compliance. In addition, it assists analysts in better understanding and applying quantitative NMR in pharmaceutical analysis laboratories.

Subject area:
Drug Products & APIs

Objectives (If applicable):
– Apply understanding of important concepts in NMR.
– Define the variables that need to be considered for an NMR experiment and explain what needs to be optimized when setting up instruments.
– Explain qualitative and quantitative NMR analysis, with an emphasis on quantitative applications.
– Distinguish between the life cycle approach and traditional approach when validating and verifying NMR procedures.
– Perform NMR in a manner that is compliant with USP documentary standards.

Target Audience (If applicable):
– Consultant
– QC Chemist
– QC Manager
– R&D
– Compendial Liaison
– Regulatory
– NMR Vendors
– Academia
– Anyone interested in qNMR and valid NMR