Table II

Accuracy and Precision (Repeatability) of FTIR Silicone Oil Assay

Expected Spiked Silicone (μg/syringe)Silicone Assayed by FTIR (μg/syringe ± SD)Percent Recovery by FTIR (% ± CV)
207203 ± 7 (n = 3)98 ± 3 (n = 3)
414373 ± 37 (n = 3)90 ± 10 (n = 3)
828839 ± 9 (n = 3)101 ± 1 (n = 3)
0 (Non-siliconized blank syringes)<LOD (n = 10)NA