| 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) |