Automated Method Development Using Analytical Quality-by-Design for Stability Indicating Methods

Library Number:
APNT135091884
Part Number:
720007480EN
Author(s):
Catharine E. Layton, Paul D. Rainville
Source:
Waters
Content Type:
Application Notes
Content Subtype:
Application Notes
Related Products:
Pharmaceutical
 
 
 
 
 
 

This application note demonstrates, the Fusion QbD Method Development Software was employed in conjunction with Empower 3 to develop a stability indicating method (SIM). This method was used to monitor Tenofovir alafenamide fumarate (TAF), an antiviral prodrug and potent inhibitor of viral reverse transcription for treatment of chronic Hepatitis B and HIV. The “Forced Degradation” feature built into the Fusion QbD Software was used to include multiple forced degradation sample preparations in a single design space. .

View the Application Note