In setting up a new method for validation studies, how important is it to calibrate the method using primary standards instead of commercial calibrators?
The method should be operated in the way intended under routine service conditions. If routine service operation will make use of commercial calibrators, then those calibrators must be part of the testing process that is validated. It is generally advisable to analyze both commercial calibrators and primary standards together, when possible, to see if they agree. Any disagreement should be resolved prior to performing the recovery, interference, and comparison of methods experiments.
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