Trust in COVID-19 Medicine: USP Methods to Assist in Detecting Falsified Remdesivir

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The global supply-and-demand imbalances caused by the COVID-19 pandemic have created a surge in substandard and falsified treatments in some regions of the world. To help safeguard patients from such counterfeit drugs and build the public’s trust in COVID-19 treatments, USP has released “USP methods to assist in detecting falsified remdesivir.” 1   This resource can help global regulators, manufacturers, and quality control laboratories to determine the identity and strength of authentic remdesivir, an antiviral drug approved and/or authorized for COVID-19 treatment in approximately 50 countries worldwide.


 

detecting falsified remdesivir

As part of USP’s ongoing COVID-19 response and in support of the Medicines We Can Trust campaign, “USP methods to assist in detecting falsified remdesivir” includes the following:

  • Analytical procedures developed by USP for determining the identity and strength of remdesivir active pharmaceutical ingredient (API) and drug product, which are essential tools for detecting substandard and falsified medicines
  • Methods using infrared spectroscopy, ultra-high performance liquid chromatography, and nuclear magnetic resonance (NMR) spectroscopy technologies along with supporting validation results
  • 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

A task force of USP staff subject matter experts in the U.S. and India developed the remdesivir resource with individual Expert Volunteers from around the world providing scientific guidance and review. Gilead Sciences, Inc., the drug innovator, supported USP by donating sample materials and methods.

“This remdesivir resource is not an official compendial standard or USP monograph. It was developed to rapidly provide information to stakeholders during the global public health emergency.”

— Dom Vicchio, Ph.D., Senior Director, Small Molecules at USP

The remdesivir task force’s key challenge was to develop and validate the methods and to deliver the remdesivir resource for use by stakeholders as quickly as possible in the midst of the COVID-19 pandemic.

“The resource that the task force delivered includes data and results derived by validated methods using innovative technologies and instrumentation,” says Jennifer Belsky, Ph.D., Senior Director, Analytical Development Laboratory at USP.

Establishing Methods to Identify Remdesivir and Detect Counterfeits

As key members of the remdesivir task force, the USP–India, Hyderabad, team developed, evaluated, and validated the methods that establish remdesivir’s identity and strength. Due to the COVID-19 pandemic, team members planned the experimental work in their laboratories when necessary and performed the data processing from their home offices equipped with remote access to USP’s high-end laboratory instruments.

hands with gloves on handling a vial

In addition, the team brainstormed to determine which compounds might be used to counterfeit remdesivir. Then they explored the analytical methods that could be used to detect those compounds.

“Determining how bad actors might think about imitating remdesivir was challenging. We worked extensively to surmise which compounds counterfeiters might try to use and then challenged our methods to establish the specificity.”
— Mayank Bhanti, Ph.D., Director, Compendial Development Laboratory (CDL), USP–India

“The remdesivir resource aims to help manufacturers, quality control laboratories, regulators and other service providers reduce the risk of substandard and falsified medicines,” says Rabin Bera, Ph.D., Director, Synthetics Laboratory, USP–India.

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.

1 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.
Remdesivir toolkit

USP Methods for Detecting Falsified Remdesivir​ includes:

  • analytical procedures developed by USP for determining the identity and potency of remdesivir API and drug product – essential tools for detecting substandard and falsified medicines.
  • methods using infrared spectroscopy (IR), ultra-high performance liquid chromatography (UHPLC), and nuclear magnetic resonance spectroscopy (NMR) technologies along with supporting validation results.

It also features 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.

This resource complements the information included in the draft World Health Organization remdesivir monograph.

Questions or feedback? Please email COVID-19@usp.org

https://doi.org/10.31003/USP.tk.remdesivir