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USP System Suitability References

Posted: Wed Oct 27, 2004 5:15 pm
by largovijay
Can I find a reference or guidance to minimum requirements for USP Resolution, Tailing and Tangent/theoretical plates. I am in the process of method validation and wanted to know if there is a recommendation for each of the system suitability parameters. Please advise.

Posted: Wed Oct 27, 2004 5:49 pm
by Kostas Petritis
I think you can find what you want here :

http://www.fda.gov/cder/guidance/4252fnl.pdf