Detecting Falsified Remdesivir

To end the COVID-19 pandemic and save lives, the world needs quality COVID-19 treatments. It is critical that regulators and manufacturers ensure therapeutics meet quality expectations. The antiviral drug VEKLURY (remdesivir) is the first U.S. Food and Drug Administration approved treatment for hospitalized COVID-19 patients. Healthcare providers around the globe are using remdesivir not only to treat patients, but also in clinical trials.

As part of our ongoing COVID-19 response, USP has developed the USP Methods to Assist in Detecting Falsified Remdesivir to reduce risks from substandard and falsified remdesivir. These methods can assist regulators and quality control laboratories to help ensure quality remdesivir is being approved, procured and distributed.
 

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 compliments 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

ssf webinar
Introduction to USP’s Methods in Detecting Falsified Remdesivir

Join us on June 22, 2021  for a free educational webinar about the USP’s methods to detect substandard and falsified remdesivir.

Register here

qnmr summit
USP qNMR Summit 2021

Want to learn more about qNMR applications, including remdesivir’s NMR-based digital spectra? Join USP and other experts from around the world to discuss the benefits of qNMR in drug development and manufacturing: October 5-7, 2021.

Reserve your place

Other COVID-19 treatment resources

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GPHF-Minilab™ Screening Tool for dexamethasone

A Concise Quality Control Guide on Essential Drugs and other Medicines: COVID-19 Special Issue

Access the screening tools

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IMWP Monographs on Favipiravir and on Favipiravir tablets

Pharmacopoeias are working together to support the global public health response to the pandemic. The recently developed IMWP monographs can help manufacturers, regulators and stakeholders fight substandard or falsified Favipiravir, an important antiviral treatment for COVID-19.

Comment on the monographs

PQM+: A Risk-Based Resource Allocation Framework
PQM+: A Risk-Based Resource Allocation Framework

A framework for risk-based resource allocation that can help regulatory agencies manage and sustainably support pharmaceutical quality assurance to achieve maximum health impact and efficiencies.

Explore the resource