Authors :
Yohan Talari; M Sunitha Reddy
Volume/Issue :
Volume 8 - 2023, Issue 10 - October
Google Scholar :
https://tinyurl.com/2fjuka25
Scribd :
https://tinyurl.com/4nnj32sw
DOI :
https://doi.org/10.5281/zenodo.10021615
Abstract :
Forced degradation studies is a stability
indicating analytical method to identify the pathway of
degradation of both drug molecule and product by
applying various stress testing conditions than
accelerated conditions. As stress degradation study is
made compulsory by various countries food and drug
agencies for regulatory and market approval of both
“Branded drugs and Generic drugs” and products
respectively. After introduction of ICH guidelines in
1993, worldwide attention gained by stress degradation
evaluation report. Hence we provide a brief overview on
the force degradation procedure, method development
for characterization and isolation of degraded products
and validation of development method.
Keywords :
Regulatory Guidelines, Forced Degradation, Method Development, Method Validation, Limits of Impurities.
Forced degradation studies is a stability
indicating analytical method to identify the pathway of
degradation of both drug molecule and product by
applying various stress testing conditions than
accelerated conditions. As stress degradation study is
made compulsory by various countries food and drug
agencies for regulatory and market approval of both
“Branded drugs and Generic drugs” and products
respectively. After introduction of ICH guidelines in
1993, worldwide attention gained by stress degradation
evaluation report. Hence we provide a brief overview on
the force degradation procedure, method development
for characterization and isolation of degraded products
and validation of development method.
Keywords :
Regulatory Guidelines, Forced Degradation, Method Development, Method Validation, Limits of Impurities.
