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Cleaning Method Validation

Posted: Sat Apr 09, 2005 2:28 am
by dinkar2005
I want to know the recovery from Coupon, I appretiate If some body will focus on this point.

Thanks

Posted: Mon Apr 11, 2005 12:25 pm
by DR
We generally spike the coupon with a known amount of a standard solution, evaporate to dryness, swab and extract the swab in a known amount of mobile phase. We do this at, above and below the limit. As long as we get a somewhat consistent recovery across the range of concentrations used (5% RSD, typically), we aren't as worried about accuracy as this can be corrected for by the addition of a "recovery factor". This is a 'fudge factor' designed to prevent anyone from under reporting results (an attempt to insure that errors are on the side of caution).

Cleaning validation

Posted: Tue Apr 12, 2005 9:44 pm
by Ben Buglio
In addition, a recovery from the coupon of ca. 80% or better would be fine.

Re: Cleaning validation

Posted: Fri Apr 15, 2005 4:14 am
by dinkar2005
In addition, a recovery from the coupon of ca. 80% or better would be fine.
Thanks DR and Ben for this information. I appretiate.

Thanks again.