Review Team (February 2016)

Bio-02 (February 2016) FOR ERP USE ONLY DO NOT DISTRIBUTE

8. CHROMATOGRAPHIC CONDITIONS 1. Mobile Phase A : 0.1% Phosphoric acid

2. Mobile Phase B : 100% Acetonitrile 3. Mobile Phase C : 80% Acetonitrile 4. Column: Phenomenex Kinetex Phenyl-Hexyl, 00F-4495-E0 (150 x 4.6mm x 2.6μm x 100Å)

5. Column Temperature: 25±2ºC 6. Retention time: 16 to 17 minutes 7. Run time: 27 minutes 8. Detector: PDA operating at 200nm (PDA scan 200 to 350nm) 9. Injection volume: 100μL

Table 2: Gradient Program Time (min) Flow rate (mL/min) Mobile Phase A (%) Mobile Phase B (%) Mobile Phase C (%) 0.0 0.6 90 10 0 18.0 0.6 90 10 0 18.5 0.8 0 0 100 24.0 0.8 0 0 100 24.5 0.6 90 10 0 27.0 0.6 90 10 0 9. SENSITIVITY Limit of Quantitation (LOQ) was calculated based on the lowest working standard and the dilution factor. LOQ = (1 x 100) / (20 x 50) = 0.1μg/100g (1ppb) 1 = 1μg/100mL lowest standard 100 = Volume (mL) 20 = 20g sample 50 = Volume (mL) loaded on immunoaffinity column 1= Final volume (mL)

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