System Suitability Sample (SST)

  • A system suitability sample (SST) must be developed during method validation. In general, the system suitability sample is a combination of all the expected analytes in the assay prepared in a suitable solvent system.
  • Analyte(s) must be at a concentration that corresponds to the low end of the calibration curve but high enough to give a robust and reproducible signal.
  • The strength and the composition of the SST solution must be documented along with a representative chromatogram generated using the SST.
  • The representative chromatogram should be used as the baseline for checking if an analytical system is suitable for conducting the validated assay. The parameters to be used for system evaluation are retention time and response.