(Hall 2) 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.
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