Other Considerations.Typically, the variations in robustness results are com-
paredtotheintermediateprecisionresultstodemonstratethatrobustnessis
not affected significantly within normal day-to-day variation. When the related
substance results are affected by some critical experimental parameters, a pre-
cautionary statement needs to be included in the procedure to ensure that this
parameter istightlycontrolledbetween experiments. Forexample, ifpercent
organic of mobile phase affects the results significantly, the procedure should
indicate the acceptable range for percent organic (e.g., 50% organic ± 2%) |
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