Performance Summary of the FTIR Method for Quantitation of Silicone Oil Extracted from Glass PFS Syringes
| Performance Factor | Summary |
|---|---|
| Specificity | Specific to the 1261 cm−1 infrared spectral peak of silicone oil (symmetrical (CH3)2-Si deformation band). Non-siliconized blank syringes read <LOD |
| Linearity | Data demonstrates a linear relationship over intended assay range (3 repeated curves), pooled data: Slope = 2.67 × 10−4 ± 0.01 × 10−4 AU per μg/mL for a 0.5 mm cell Intercept = 0.0053 ± 0.0008 AU Correlation Coefficient (R2) = 0.9995 Standard Error = 0.001623 |
| Accuracy (recovery of spike) | 90–101% |
| Precision (repeatability of spike) | 1–10% |
| Precision (intermediate precision) | 9% |
| Estimated precision (reproducibility) | 9% |
| Estimated limit of quantitation, LOQ (not required) | 61 μg/mL |