Bioequivalence and Bioavailability Forum

Good Evening,

Our practice is that as long as the peak shape is acceptably symmetric and the injection volume is consistent within a batch (run), then there is no problem from a regulatory point of view with changing the injection volume. A statement in the method description along the lines "injection volume may vary in order to maintain the assay performance, but it must be consistent throughout a run" may help. It is a good idea to test in method development the extent to which increasing the injection volume may help (nice to have a backup plan).

Cheers!