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baseline stability criteria

Posted: Thu Mar 20, 2008 2:15 pm
by coquim
Hi people!...
i´d like to know the correct baseline stabilty criteria before to start running...i mean, what is the correct detail level (mv) must i see and what is the acceptable slope and drift that i must expect no matter solvents i´m using...
Thanks to all!

Posted: Thu Mar 20, 2008 7:03 pm
by JGK
I suggest you refer to http://www.ich.org/cache/compo/276-254-1.html

and download the document "Q2(R1): Validation of Analytical Procedures: Text and Methodology"

This is pretty much the "industry" Standard