USP Methods to Assist in Detecting Falsified Remdesivir

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.