Physicochemical Characteristics of Transferon™ Batches

Figure 1

Reversed-phase chromatographic profile of Transferon. Comparison between sample matrix (black line) and batch 15A01 of Transferon (blue line). Chromatographic profile exhibits 4 main peaks with and absolute retention time of 2.2 min (P1), 4.3 min (P2), 6.4 min (P3), and 8.2 min (P4). Figure S1 shows that this chromatographic profile is consistent between the 10 analyzed Transferon batches. Transferon samples were analyzed using an Acquity™ UPLC™ BEH300 C18 chromatographic column (2.1 mm × 150 mm) and TFA (0.1%)-H₂O and TFA (0.1%)-acetonitrile as the mobile phase at 0.4 mL/min using a gradient configuration. The column temperature was maintained at 30°C, and UV detection was performed at 214 nm. Chromatographic profiles were analyzed using Empower™ (ApexTrack method) to obtain the relative area percentage and absolute retention time for each peak. AU: area units.