Bioequivalence and Bioavailability Forum

Dear All

Good Morning (As per IST)

I have a question regarding maximum permissible specification limits for impurity.

What will be or is the maximum permissible specification limits for impurity in US ANDA filings specially in the case where the impurity formed is a metabolite in vivo and the drug in this case is Prodrug

FDA guideline does not mention about the specification limit like 3%,5% or more or explicitly mention the levels.

How to proceed other than qualification of impurity through tox studies?

Any way out for such conditions and classical examples where FDA approved ANDA

looking for some insight!

Regards

Luvblooms