By Sean on Monday, March 10, 2003 - 05:33 pm:
Hello
I need to know what are the normal specification for recovery study under method validation for:
Potency Assay
Impurity assay
Dissolution assay
Thanks
By Chempara on Wednesday, March 12, 2003 - 10:36 am:
Hi
Recovery is another way to measure the accuracy of your method.
If your method has good accuracy then your recovery should be near a 100%
In case your not just detecting but also quantifying the impurities in your sample then the recovery has the same specifications as indicated in potency assay thus around 100%
Finally for dissolution testing idon't think that recovery has any meaning incase you are using commercial tablets, because you do not know the exact ammount of active substance in them. You can only compare the labelled amount with the amount you found using your method and compare the results with another method, perhaps describe in an DMF or in National Pharmacopoeias
By Anonymous on Wednesday, July 9, 2003 - 03:20 pm:
Look at the ICH guidelines on this subject. They are your best bet for making sound decisions.
By Heil on Monday, July 21, 2003 - 07:01 am:
I´m also looking for recovery acceptance criteria at the LOQ. Do you have further information meanwhile? From my experience the ICH guidelines are not very detailed in that question.
By Anonymous on Monday, September 22, 2003 - 06:02 pm:
80-120% for QL
By Anonymous on Tuesday, September 23, 2003 - 07:31 am:
Hi !
for potency assay 95%-105%
for impurity assay 75%-125%
i'm not sure but it should be 95%-105% for dissolution tests.