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Article History

Received: 12 August 2024

Accepted: 1 December 2024

First Online: 20 January 2025

Declarations

:

: Certain commercial equipment, instrument, or materials are identified in this article to adequately specify the experimental procedure. Such identification does not imply approval, endorsement, or certification by USP of a particular brand or product, nor does it imply that the equipment, instrument, or material is necessarily the best available for the purpose, or that any other brand or product was judged to be unsatisfactory or inadequate. The NMR raw data can be shared, as requested.

: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

: This study is based on one of the US Pharmacopeia’s incubated projects. All sources of funding for the research reported are from US Pharmacopeia.

: The authors gratefully acknowledge support from the Digital and Innovation team at USP. In particular, we would like to recognize the collegial support from Dr. Jaap Venema, Dr. Gabriel Giancaspro, Mr. Michael Levy, Dr. Michael Ambrose, and Mr. Jie Liu; and proofreading support from Mr. Doug Podolsky. The authors are also grateful to Drs. Hendrik Henning and Bernd Diehl of Steelyard Analytics for qNMR method development and validation. We also would like to express our gratitude to Dr. Matt Leclerc at Nanalysis Scientific Corp. for their invaluable support in testing the USP-ID. Finally, we would like to recognize Drs. Michael Nelson and Aaron Urbas from National Institute of Standards and Technology (NIST) for permitting access to the Magritek NMR instrument (Spinsolve 60).

: Not applicable.

: Not applicable.