TABLE III

System Suitability Requirements

ParameterCriteria
Wavelength calibration or detector tuningMust successfully calibrate or tune
Lowest quantity determinableNot more than lowest qualified standard concentration (typically 0.05 μg/mL)
Correlation coefficient for standard curver ≥ 0.995
Standard percent error, for recovery of standardsNMT 30% @ ≤0.5 mg/L NMT 10 % @ >0.5 mg/L
Laboratory control (LC) sample, analyzed at the beginning, end, and periodically the throughout runRecovery of 100 ± 20%
Supplemented sample (SS) recoveryRecovery of 100 ± 30%
%RSD on replicate measurement for working standard and sample solutions with analyte concentrations greater than 1 mg/LNMT 10%
Internal standard ratio (blank) to sample response0.7–1.3
  • NMT = not more than.