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Articles on FDA Requirement?
Posted: Fri Dec 01, 2006 8:22 am
by theman
Hello, I've heard that the FDA requires the Resolution Factor be greater or equal to 2; are there any articles indicate this FDA specification? Additionally, is there any specification on the Tailing factor and Plate Count? Please help. Thank you very much.
Posted: Fri Dec 01, 2006 9:27 am
by Sunjay
Dear Theman,
For your method you need baseline separation, and this will be achieved if your method resolution is 1.5.
I do not know any requirement of USFDA for resolution of 2.
If ur method is able to give basline separation there is no problem.
Regards
Posted: Sat Dec 02, 2006 12:38 am
by tom jupille
It's not a
requirement, but rather a
suggestion:
http://www.fda.gov/cder/guidance/cmc3.pdf
I believe the ICH is similar.
Posted: Sat Dec 02, 2006 7:07 pm
by Consumer Products Guy
We've used 2.0 as our target here, figuring that it may get worse over time (to 1.5 baseline resolution) as the column "ages".