Bioequivalence and Bioavailability Forum

Hi,

❝ So shall we use stored calibration standards for evaluation of PA during validation, if we prove Long term matrix stability at the end of validation?

Yes you can, as long as you demonstrated the long term matrix stability of your analyte.

But the critical question is this: which CC did you use in demonstrating long term stability? Was the curve gotten from freshly prepared calibration standards? This is because only CCs from freshly prepared standards are to be used for stability determination.

Regards,