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.

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

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