Abstract

Relevance of Forced Degradation Studies and Protocol for Characterization of Degradation Products Using Mass Tools

Saranjit Singh, Professor/Head, NIPER Mohali

Forced degradation is a term synonymous with many other phrases like stress testing, forced decomposition study, stress study, stress degradation study and stress decomposition study. The same was formalized under the heading ‘stress testing’ by ICH in its parent stability testing guideline Q1A in 1993. It has now been extended to generic drugs. The topic has attracted huge interest from regulatory agencies globally and also scientists working in industry as well as academia. The presentation will focus on relevance of forced degradation studies and on protocols for the characterization of forced degradation products at the level of ~0.1% using mass spectrometry tools. The same will be duly explained through multiple case studies from our lab or the literature.