By Joe Ray and Toru Miura
Quantitative NMR (qNMR) is a metrologically traceable methodology and widely used in many fields, such as food, chemical and pharmaceutical analysis. However, the industrial and
regulatory stakeholders have required more advanced guidance, in terms of method principle, parameter setting, data processing and method development and validation. On July 1, 2022, the US Pharmacopeial Convention published a draft revision of General Chapter Nuclear Magnetic Resonance Spectroscopy for public comments. This presentation will introduce the revised draft in detail, focusing on the key issues in qNMR analysis, such as establishment of metrological traceability, uncertainty measurement, and practice of lifecycle concept in qNMR analytical method validation.
Session #5: Super Session (Part 1): qNMR Advanced Session and Updates, presented by US Pharmacopeia