full validation versus verification of compendial methods

[srdales]

How much variation to compendial method is one allowed before a full validation is required?

Stationary phase? Diameter? Mobile phase composition?

If there is a reference, please provide.

[EH]

As for compendial method verification, we evaluate accuracy, intermediate precision and stability indication.

[tom jupille]

There was a proposal in Pharmacepeial Forum a couple of years ago defining "default" adjustement ranges, but as far as I know, it has not yet become officially accepted by USP.

The FDA has an "internal" specification:
http://www.fda.gov/ora/science_ref/lm/v ... _04_05.pdf
but strictly speaking, this does not apply to compendial methods, so use it at your own risk.

[Sunjay]

The variation to a compndial method for mobile phase, columns dameters is given in British Pharmacoepia.

For the verification of a compendia method we are studying following parmaters for the formulations:

Stability of solution, specificity, filter compatibility and precision.

Regards