Forced degradation study for Compendial procedure

[ananthjkumar]

Is it require to perform the forced degradation study if using compendial procedure.

whether directly can use as stability indicationg method(compendial procedure)

[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....

[ananthjkumar]

If I am not going to use for stability study then as per regulatory is it not required?

[sharma]

Yes forced degradation may not be required. But you have to check the few parameters of validation like specificity, LOD/LOQ, Precision etc.