limits on 100 % recovery active

[scio2]

Hi, the limits for the check standard in pharmaceutical analysis at 100 % recovery is typically 98-102 %. Does anyone have a reference for where this figure comes from

Thanks


Scio

[michaelcarolus]

Hi Scio

I think these limits are based on the accuracy of the method. If your method accuracy has a limit of 98 - 102% then your std recovery would also be the same. We generally use a recovery value of 98 - 102 % for the API and 10% for degradation/impurities.

Thanks