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Forced degradation study for Compendial procedure
Posted: Fri Dec 09, 2011 7:30 am
by ananthjkumar
Is it require to perform the forced degradation study if using compendial procedure.
whether directly can use as stability indicationg method(compendial procedure)
Re: Forced degradation study for Compendial procedure
Posted: Tue Dec 13, 2011 4:03 am
by sharma
If you are using the method for stability studies, then it is recommended to go for forced degradation studies, to establish that the method is stability indicating for your product....
Re: Forced degradation study for Compendial procedure
Posted: Tue Dec 13, 2011 4:10 am
by ananthjkumar
If I am not going to use for stability study then as per regulatory is it not required?
Re: Forced degradation study for Compendial procedure
Posted: Tue Dec 13, 2011 10:52 am
by sharma
Yes forced degradation may not be required. But you have to check the few parameters of validation like specificity, LOD/LOQ, Precision etc.