Solid-state NMR Spectroscopy in the USP-Pharmacopeial Forum

Solid-state NMR Spectroscopy in the USP-Pharmacopeial Forum

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The Quantitative NMR Spectroscopy Expert Panel of The United States Pharmacopeia (USP) intends to provide comments and seek feedback on a newly proposed informational General Chapter <1762> Solid-State nuclear Magnetic Resonance Spectroscopy – Theory and Practice in PF 50(2). which focuses on solid-state NMR (ssNMR) spectroscopy. This chapter provides useful guidance on current scientific approaches for the analysis of solid pharmaceuticals.

While the use of ssNMR to characterize critical quality attributes (CQAs) of pharmaceutical substances, products and excipients has been demonstrated in literature, its integration into routine quality control remains limited. The USP invites interested stakeholders to participate in an Open Forum to discuss the newly proposed USP General Chapter <1762> Solid-State nuclear Magnetic Resonance Spectroscopy – Theory and Practice in PF 50(2).

Objective

The Open Forum is intended for people chemists/scientists and researchers working in pharmaceutical quality assessment using ssNMR spectroscopy to learn about USP’s newly proposed General Chapter <1762> Solid-State nuclear Magnetic Resonance Spectroscopy – Theory and Practice. Participants will have the opportunity to provide feedback and help USP identify challenges.

Pre-read:

  • Introduction to solid-state NMR spectroscopy chapter <1762>Solid-State nuclear Magnetic Resonance Spectroscopy – Theory and Practice

Who should participate?

Quality control analysts and physical analysis chemists in physical material characterization, suppliers of raw input materials, including excipients, testing laboratories and regulators.

For further information, please contact Yang Liu (yang.liu@usp.org)

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