Effect of Stainless Steel on Polysorbate 80/20 Oxidation, 15 Days at 25 °C1
| Sample | Histidine + Polysorbate 80 | Histidine + Polysorbate 20 | ||
|---|---|---|---|---|
| Day 0 | Day 15 | Day 0 | Day 15 | |
| Appearance | Clear and colorless | Pale yellow | Clear and colorless | Clear and colorless |
| Polysorbate 80 Content | 0.06% | 0.005% | Not tested | Not tested |
| LC-MS | ||||
| Oxidation of saturated FA | 0% | 7% | 0% | 8% |
| Modification of histidine | 4.5% | 0% | 7% | |
↵1 Study conducted in cleaned and passivated stainless steel containers.