TABLE I

Effect of Contact Material on Polysorbate 80 Degradation, 7 days at 25 °C1

SampleTime PointContact Material
Glass (Control)BagStainless SteelStainless Steel + N2
Polysorbate 80 Content00.06%0.06%0.06%0.06%
7 days0.06%0.06%0.005%10.05%
Appearance0Clear & colorlessClear & colorlessClear & colorlessClear & colorless
7 daysClear & colorlessClear & colorlessPale yellowClear & colorless
  • 1 LC-MS indicated 1.9% of intact (i.e., un-oxidized) oleic acid.