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SEC (GPC) metod validation?

Posted: Tue Nov 02, 2010 11:57 am
by canhasan
How do you validate your SEC method for proteins? Which validaton parameters do you apply? And your limits? Thanks ! :wink:

Posted: Tue Nov 02, 2010 2:03 pm
by cody84
ICH has a guideline for bioanalytical methods...the acceptance criteria is much nicer to work with.

Posted: Fri Nov 05, 2010 9:44 am
by canhasan
Have you ever tried to inject the limit %2 of the main peak to get repeatability of six injection?