As part of USP’s response to the COVID-19 crisis, a Remdesivir Toolkit containing analytical procedures (e.g., IR, UPLC, NMR, LC-MS) of identification and/or assay is in development. This course will cover the use of the toolkit, which can identify and reduce the risk of substandard and counterfeit Remdesivir and would support the digital/electronic standards model under evaluation.

Subject area:
Drug Products & APIs

Objectives (If applicable):
• Analyze data developed in the Remdesivir Toolkit.
• Demonstrate analytical methods of ID and assay test for Remdesivir (e.g., IR, UPLC, LC-MS, qNMR—both high-field and benchtop platforms).
• Explicate each validation protocol of analytical methods and (digital) spectral information of Remdesivir.

Target Audience (If applicable):
• Analytical scientists
• QA/QC analysts
• R&D scientists and managers
• Regulatory affairs specialists
• Contract research and manufacturing organizations staff