Bioequivalence and Bioavailability Forum • Release Test

BEAZ
★

India,
2008-12-02 08:49
(6420 d 01:20 ago)

Posting: # 2854
Views: 3,283

Release Test [Regulatives / Guidelines]

Dear All,
I welcome :-)

your comments and suggestion for the below query
The FDA guidance "Handling and Retension of BA and BE Testing Samples" state that reserve sample should be 5 times to perform the release tests.
Is the release test include only dissolution or the entire tests which are performed as per the specifications?
What about :confused:

injectable suspension and oral suspensions.
Thanks and regards

—
Alhas

krishnamurthy ca ☆ 2008-12-02 11:18 (6419 d 22:51 ago) @ BEAZ Posting: # 2861 Views: 2,822	Release Test Post reply
	Dear Alhas release tests includes all the tests required (like identification, assay etc) to certify the product as satisfactorily meeting release specification. rgs Krishnamurthy -- Edit: Full quote removed. Please see this post! [Helmut]

BEAZ ★ India, 2008-12-03 08:54 (6419 d 01:14 ago) @ krishnamurthy ca Posting: # 2872 Views: 2,748	Release Test Post reply
	Dear Krishnamurthy Thank you and in case of injectable we will be performing test for sterlity, is this come under release test? beacause if we consider this then there will be a remarkable increase in the quantity of retention. rgs — Alhas

krishnamurthy ca
☆

2008-12-04 05:54
(6418 d 04:14 ago)

@ BEAZ
Posting: # 2874
Views: 2,721

Release Test

Post reply

Dear Alhas
tests for sterility is for the quality of the product (agree that its a release test), and this is in no way performed to identify or determine the potency of the active ingredient. hence such tests can be skipped.

others can comment.
rgs
Krishnamurthy

--
Edit: Full quote removed (like in this post of the same thread). Please see this post! On the next occasion your account will be blocked without further notice. [Helmut]