Bioequivalence and Bioavailability Forum

Dear Sachin,

❝ Please tell how do we consider release test.

Normally release tests are as per your product release specification and it may comtains following (but not limited to)

a) Identification
b) Assay
c) Relative substance data
d) Dissolution
e) Content Uniformity
f) Microbial assay

For release of reference product one need to have atleast following test
a) Identification
b) Assay
c) Relative substance data
d) Dissolution

You should discuss the same with your QA team to get a better clarity on the same.

Regards