By robert j. burgess on Monday, January 12, 2004 - 04:33 am:
For what sorts of tests is a non-stability indicating HPLC assay justified when testing pharmaceutical products. For instance, is a non-stability assay HPLC method OK for dissolution, cascade impaction, bulk assay and content uniformity testing?
By Bharat kumar agarwal on Thursday, May 6, 2004 - 05:44 am:
Dear robert j. burgess
You should be use the validated stability indicating method according to regulatory requirement.And yes non-stability assay HPLC method OK for dissolution, cascade impaction, bulk assay and content uniformity testiing.
Bharat
By Anonymous on Saturday, May 8, 2004 - 07:41 am:
A method has to be stability indicating if you will be running the test for samples on stability. The idea being that when you test samples on stability you are looking to see if degradation has occured: and you can't do that unless you know that the method will register if some of the analyte is dissappearing (i.e. degrading). You don't need a method to be stability indicating for tests that are only performed on release. There it is assumed that no degradation has occured (in the short time since manufacturing).
One correction to the comment above: a content method *does* have to be stabiity indicating, because content testing is done on stability.