Articles on FDA Requirement?

[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.

[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

[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.

[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".