to validate any analytical method with the approach of accuracy profile we are obliged to verify the system of suitability test of each method
I found in some article that RSD "relative standard deviation" should be less than 1% even for the RSD AIRE or RSD retention time
my question is their any recommandation from guide-line for this pourcentage ?
System suitability is routinely assessed before an analytical run. Data generated from system
931 suitability checks should be maintained in a specific file on-site and should be available for
932 inspection. System suitability samples should be different from the study samples, standards, and
933 QCs to be analyzed in the run. Therefore, study samples, standards, or QCs should not be used
934 as their own system suitability samples within the analytical run.
Acceptance criteria usually follows by industry is %CV for RT is
It serves as a measure whether your system suitable to carry out the test you are doing.
Are you doing something related to chromatography? I guess it as you mentioned retention time.
I involved in several test for pharmaceutical product and I'm referring to United State Pharmacopoeia.
Hope these can help you.
System suitability testing is an integral part of many analytical procedures. Tests are based on the concept that the equipment, electronics, analytical operations and samples to be analyzed constitute an integral system that can be evaluated as such. System suitability is checked by calculating the tailing factor (T), column efficiency (N), resolution (Rs) factors. All the calculated parameters are within the acceptable limits indicating good selectivity of the method and ensuring system performance
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