TABLE II

Operating Parameters for the LC/MS/MS Method for Measuring DEHP in the Albumin and Polysorbate 80 Test Extracts

Operating ParameterOperational Condition
ColumnPhenomenex Kinetex C18, 50 × 2.1 mm, 2.6 μ particle size
Column Temperature40 °C
Injection Size2 μL
Mobile Phase A10 mM Ammonium formate + 0.1% formic acid in water
Mobile Phase B0.1% Formic acid in acetonitrile
Mobile Phase GradientTime (min)% Mobile Phase B
082
1.8582
1.9098
2.5098
2.5582
3.0082
Mobile Phase Flow Rate0.6 mL/min
MS Operating ModeAPCI, + ion
MS/MS Scan SegmentsFor DEHP, m/z = 391.3/149 amu; for DOP D-4 (internal standard), m/z = 395.3/153 amu