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Recovery acceptance criteria
Posted: Wed Nov 30, 2022 8:54 am
by 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
Re: Recovery acceptance criteria
Posted: Wed Nov 30, 2022 1:26 pm
by 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.
Re: Recovery acceptance criteria
Posted: Wed Dec 21, 2022 8:42 am
by snisyriou
So, is it acceptable an upper limit of 130% (on the limit level) for degradation impurities, for very unstable samples?
Re: Recovery acceptance criteria
Posted: Wed Dec 21, 2022 3:59 pm
by 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.