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Method validation - System suitability

Posted: Mon Oct 29, 2007 7:44 am
by bioram
Please let me know that System suitability schedule in method validation cycle

Posted: Mon Oct 29, 2007 12:30 pm
by wanda50
I'm not sure what your question is exactly, but I will take a stab at answering.

You always need to establish system suitability according to the method and your company's SOP BEFORE you can begin your analyses. Additionally, you should (must) insert suitability injections through out the experiment to ensure that system suitability is maintained through the experiment. How often you insert the system solutions should be determined by your SOP. Our guideline is 10 injections.

Hope this answers your question.