Residual Hydrogen Peroxide in mAb Formulation (60 mg/mL) Spiked with Various Concentrations of H2O2 as Measured by Amplex® UltraRed Assay
| Temperature (°C) | Time (months) | H2O2 Concentration (ng/mL) | |||||
|---|---|---|---|---|---|---|---|
| 0 (Unspiked Control) | 50 | 100 | 200 | 300 | 3000 (Positive Control) | ||
| 2–8 | 0 | <LOD | 46.6 | 95.4 | 195.9 | 301.6 | 2927.5 |
| 1 | <LOD | <LOD | 8.6 | 24.6 | 43.1 | 619.3 | |
| 3 | <LOD | <LOD | <LOD | <LOD | <LOD | 11.8 | |
| 6 | <LOD | <LOD | <LOD | <LOD | <LOD | <LOD | |
| 9 | NT | NT | NT | NT | NT | NT | |
| 12 | NT | NT | NT | NT | NT | NT | |
| 25 (60% RH) | 1 | <LOD | <LOD | <LOD | <LOD | <LOD | <LOD |
| 2 | <LOD | <LOD | <LOD | <LOD | <LOD | <LOD | |
| 3 | NT | NT | NT | NT | NT | NT | |
| 6 | NT | NT | NT | NT | NT | NT | |
| 40 | 0.25 | <LOD | <LOD | <LOD | <LOD | <LOD | <LOD |
| 0.5 | <LOD | <LOD | <LOD | <LOD | <LOD | <LOD | |
| 1 | NT | NT | NT | NT | NT | NT | |
LOD, limit of detection; NT, not tested; RH, relative humidity.