Bioequivalence and Bioavailability Forum

Dear Ramesh,

Personally I would not bother too much about solvent dispensers. You may get a question from an auditor or an inspector, be ready to explain why it is not relevant. The question will then be, whether the auditor or inspector understand what he does or not, and you can never know in advance .

On the other hand, there are so many sources of variability in a method that having control over one can't hurt you. If the solvent volume is dispensed with a correct repeatability, you will limit the variability of your IS response, which is another source of discussions !

So to summarise: I would consider checking the solvent dispenser as not vital, but still of use.

Regards
Ohlbe