Recovery acceptance criteria

[snisyriou]

Hello!

does anybody know, if there is a guideline that defines the acceptance criteria of recovery in a related substances method validation?


Thank you in advance

[millerk8561]

Hello!

does anybody know, if there is a guideline that defines the acceptance criteria of recovery in a related substances method validation?


Thank you in advance

It's going to depend entirely on your lab's governing body.

[snisyriou]

So, is it acceptable an upper limit of 130% (on the limit level) for degradation impurities, for very unstable samples?

[tom jupille]

If this were my problem, I would dive into the literature and look at existing (preferably published) methods for the same or similar types of samples. That would give me a feel for what is generally accepted.