Injection Type # of injections Parameter(s) Acceptance Criteria
Diluent Blanks ≥ 1 injected at the beginning of the sequence Concentration ≤ LLOQ
System Suitability Test (SST) Injections ≥ 3 points injected at the beginning of the chromatographic sequence following the diluent blank Retention Time (tR) As per SOP
Peak Response
Tailing Factor (T)
Theoretical Plates (N)
Capacity Factor (k’)
Resolution (Rs)
Multi-Point Calibration Curve ≥ 5 points injected immediately following the SST injections Coefficient of Determination (R2) ≥ 0.99
y-intercept Not significantly different than 0
Single-Point Calibration Curve ≥ 5 points injected immediately following the SST injections Coefficient of Determination (R2) ≥ 0.99
y-intercept Not significantly different than 0
Stock Standard Comparison ≥ 5 injections of the stock standard diluted to mid range of a multipoint curve concentration or to the single point curve concentration Concentration (PR) 100 ±5% difference
Performance Checks Same solution as SSTs; bracketing 10 or less samples Concentration (PR) 100 ±5% nominal
Post-Processed Samples  ≥ 3 injections of each sample preparation Concentration (PR) Solutions 100 ±10% (PR) ≤ 10 (%RSD)
Concentration (PR) Suspensions 100 ±15% (PR) ≤ 10 (%RSD)
Concentration (PR) Feeds / Solid Matrices 100 ±20% (PR) ≤ 15 (%RSD)
Table 4 : Sample Analysis Parameters and Acceptance Criteria