Examples of FTIR Silicone Assay Data Obtained for Multiple Lots of Syringes with Ages of Less than 4 Months with 0.25 and 0.4 mg Nominal Initial Silicone Oil Targets
| Lot | Initial Nominal Target (mg) | Silicone Assayed by FTIR (μg/syringe ± SD) | Percent of Initial Nominal Target (%) | Coefficient of Variation, CV (%) |
|---|---|---|---|---|
| A | 0.25 | 210 ± 16 (n = 10) | 84 | 8 |
| B | 0.25 | 193 ± 12 (n = 10) | 77 | 8 |
| C | 0.4 | 436 ± 29 (n = 10) | 109 | 7 |
| D | 0.4 | 358 ± 35 (n = 10) | 90 | 10 |
| E | 0.4 | 357 ± 45 (n = 10) | 89 | 13 |
| F | 0.4 | 361 ± 15 (n = 10) | 90 | 4 |