Peroxide Residual and Oxidation of 10 mg/mL mAb2 in Phosphate Buffer at pH 6.2 Spiked with 500 ng/mL H2O2 at 30 °C Storage
| Test Procedure | Time Point (days at 30 °C) | Control | Type of H2O2 | |
|---|---|---|---|---|
| Unstabilized | Stabilized | |||
| Amplex® UltraRed HRP Assay—Peroxide (ng/mL) | 0 | NA | 511 | 570 |
| 1 | NA | 481 | 555 | |
| 2 | NA | 447 | 530 | |
| 4 | NA | 372 | 488 | |
| 7 | NA | 328 | 340 | |
| 11 | NA | 236 | 276 | |
| 14 | NA | 193 | 228 | |
| 21 | NA | 119 | 88 | |
| Peptide Mapping—HPLC | ||||
| % Met 252 Oxidation | 0 | 0.9 | 1.1 | 1.2 |
| 21 | 1.2 | 5.8 | 6.1 | |
| % Met 428 Oxidation | 0 | 0.5 | 0.5 | 0.5 |
| 21 | 0.7 | 2.6 | 2.7 | |
HPLC, high-performance liquid chromatography; HRP, horseradish peroxidase; NA, not applicable.