Chromatography Forum

Hi all

Is really necesary to perform linearity (titration) in the validation of a method for a finished product?
Consulting in the internet I have two different views, in my humble opinion is no necesary, but I consult youin the Forum.

Fernando.

Dear Fernando

You definitely need to do a titer determination of the titrant. You also need to proof that the dosing device (burette) delivers what is said it does. You either qualify your device or run a linearity test.
If your dosing device is qualified already I assume that you do not need to run al liearity test.

But finally your SOP will decide.

Dear Markus

Thank you for yor reply, I forgot to mention that I am using a glass burette
of 25 ml. Yes I agree with you that qualifying the burette is mandatory then linearity is not necessary.

Best regards

Fernando

Here we do not qualify glass burets, volumetric pipets, or volumetric flasks, and we do GxP work. We qualify automatic titrators, dispensers, eppendorf style pipets, etc.

Here we do determine linearity with validated GxP titration assays, but I can't say that I agree fully with this. To me, that's like "proving" that titrations themselves are a way to assay materials.