Bioequivalence and Bioavailability Forum

Hi Ionsource!

❝ Please let me know if this difference in the method of solution preparation is significant enough to invalidate our previously done studies?

Duno. The inspector is right since depending on the compound in the worst case you may face volume contraction/dilation. Although rare if dissolving a solid (more likely mixing two liquids), but existing. Talk to an oceanographer about sea salinity.
On the other hand you can easily compare your previous method to the one he suggested.

❝ Secondly, which method is more practical to work with?

Use volumetric flasks in the future – actually I never have seen anything else in the past. In my experience the 10 mL ones are terrible to handle. If possible weigh in more and use a 20 or 25 mL flask.