Developing Analytical Chromatographic Methods for Pharmaceutical Stability Investigations

Library Number:
APNT134949157
Part Number:
720006037EN
Author(s):
Thomas Swann
Source:
Waters
Content Type:
Application Notes
Content Subtype:
Application Notes
Related Products:
 
Forced Degradation
 
 
 

This application describes a case study where a Quality by Design (QbD) approach was used to develop an analytical stability indicating method for monitoring degradation of amoxicillin powder for oral suspension.

A Quality by Design approach was illustrated, leveraging the software assistance of Fusion QbD to select factor value combinations, create acquisition methods, and evaluate modeled responses. The resulting Stability Indicating Method has sufficient resolving power to separate the worst case mixture of analytes afforded by a forced degradation sample. This gives confidence that this SIM will be able to separate whatever degradants arise during long term and accelerated pharmaceutical stability investigations.


Title Format File Size
Download PDF PDF 1180.09kB