Effect of Stainless Steel on Histidine and Polysorbate 80 Ratio on Polysorbate 80 Oxidation, at 25 °C1
| Test | Time Point | 50 mM Histidine + 0.06% Polysorbate 80 | 50 mM Histidine + 0.01% Polysorbate 80 | 5 mM Histidine + 0.06% Polysorbate 80 | 5 mM Histidine + 0.01% Polysorbate 80 |
|---|---|---|---|---|---|
| Polysorbate 80 Content | 0 | 0.057% | 0.009% | 0.057% | 0.009% |
| 1 week | 0.016% | 0.006% | 0.053% | 0.009% | |
| 2 week | None detected | 0.0003% | 0.026% | 0.0004% | |
| Appearance | 0 | Clear and colorless | Clear and colorless | Clear and colorless | Clear and colorless |
| 1 week | Clear and colorless | Clear and colorless | Clear and colorless | Clear and colorless | |
| 2 week | Clear and colorless | Clear and colorless | Clear and colorless | Clear and colorless |
↵1 Study conducted in cleaned and passivated stainless steel containers.