Cleaning Method Validation

[dinkar2005]

I want to know the recovery from Coupon, I appretiate If some body will focus on this point.

Thanks

[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).

[Ben Buglio]

In addition, a recovery from the coupon of ca. 80% or better would be fine.

[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.