Identifying Remdesivir With NMR-Based Digital Spectra
The resource includes a quantitative NMR (qNMR) method using high-field and benchtop NMR instruments that was found to be specific, linear, accurate, repeatable, and robust for remdesivir analysis. In addition, it provides USP’s first NMR-based digital spectra for determining the identity and purity of remdesivir API without a physical reference standard when using either high-field or benchtop NMR instruments.
“The methods and supporting validation data described for NMR spectroscopy procedures are suitable for establishing the identification of remdesivir in the presence of potential impurities from raw materials or manufacturing processes,” says Yang Liu, Ph.D., Incubated Projects Manager, Product Quality & Analytical Methods, at USP.
USP will present this work along with other advances in NMR instrumentation and data analytics at the virtual USP qNMR Summit 2021 on October 5–7, 2021, as well as at events in South Asia and China this fall.
The remdesivir resource is the latest in a suite of resources created in collaboration with our partners to help manufacturers, regulators, and quality control laboratories ensure quality and trust in medicines approved or authorized to prevent and treat COVID-19. USP has also collaborated with other international pharmacopeias on an interactive dashboard of monographs mapped to medicines being investigated as COVID-19 treatments. You can learn more about these resources and our broader efforts at USP’s COVID-19 response hub.
The USP methods to assist in detecting falsified remdesivir is not a USP compendial standard. It was developed to provide rapid information for stakeholders in light of the global public health emergency and is intended to serve as a resource for informational purposes only. This document was developed by USP and reviewed by expert volunteers. No public comment period was employed due to the public health emergency posed by COVID-19. It does not reflect USP or USP’s Expert Body opinions on future revisions to official text of the USP–NF. Parties relying on the information in this document bear independent responsibility for awareness of, and compliance with, any applicable federal, state, or local laws and requirements. USP is actively monitoring the evolving situation and will update this document accordingly.