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Article pubs.acs.org/JACSNMRBased Determination of the 3D Structure of the LigandProtein Interaction Site without Protein Resonance Assignment Julien Arts,×, Marielle Alike Was ti, May Marsh, Laura
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NMR-based determination of form refers to the process of using Nuclear Magnetic Resonance (NMR) spectroscopy to identify and characterize the form or structure of a substance, often in the context of chemical compounds or pharmaceuticals.
Entities that manufacture or distribute substances that require NMR analysis for regulatory compliance or quality control are typically required to file an NMR-based determination of form.
To fill out the NMR-based determination of form, one must provide detailed information about the substance, including its chemical structure, NMR spectra, and relevant analytical results. Follow the specific guidelines provided by the regulatory authority.
The purpose of the NMR-based determination of form is to ensure that substances are correctly characterized and compliant with regulations, to guarantee safety, efficacy, and quality in their use.
The report must include the chemical identity of the substance, detailed NMR data, interpretation of results, analysis methodology, and any relevant supporting information to confirm the findings.
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