EP HPLC method validation..what parameters do i need?
Posted: Tue Oct 20, 2009 9:24 am
by seamoro
Just wondering if my Method is in the EP ...what parameters do i need to validate for?....System Suit...Specficity..Method Precision...Stability in Solution??? Im validating for Related Substances and Assay.
Posted: Tue Oct 20, 2009 9:29 am
by Alex Buske
Ask your Q person.
Pharmacopoeial methods can be taken as validated. However, they often don't work well and need to be adjusted. So validation will be necessary again.
Posted: Tue Oct 20, 2009 10:01 am
by krickos
Hi Seamoro
As Alex indicated, one typically have to do a "case by case" approach.
The links below from previous discussions may help:
viewtopic.php?p=49713&highlight=#49713
viewtopic.php?p=47849&highlight=#47849