Method Validation Data for Aluminum in Pre-Filled Syringe Placebo Drug Formulation
| Sample | % Recovery | Relative Standard Deviation (RSD) (n = 3) |
|---|---|---|
| Accuracy/Precision: 2 ppm | 112.3 | 2.1 |
| Accuracy/Precision: 10 ppm | 111.3 | 1.7 |
| Accuracy/Precision: 20 ppm | 111.8 | 1.4 |
| Intermediate Precision: 10 ppm | 116.5 | 1.0 |
| Specificity: 10 ppm | 101.7 | NA |
| Robustness: 10 ppm1 | 106.8 | 2.3 (n = 12) |
↵1 Robustness − mass ± 20%, digest ± 5%, pump speed ± 5%.