limits on 100 % recovery active
Posted: Wed May 28, 2008 12:32 am
by 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
Posted: Wed May 28, 2008 5:33 am
by 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