Table 6D.
Overview of published stress studies related to polysorbate degradation using 2,2-azobis(2-amidinopropane) dihydrochloride (AAPH). AAPH concentration, temperature, pH, buffer conditions, study duration, polysorbate concentration, and polysorbate quality are summarized. Abbreviations: His: histidine, w: weeks, m: month, h: hour, HP: high-purity, AL: all-laurate, AcOH: acetate, BHT: butylated hydroxytoluene.
| Study | AAPH / mM | Temperature / °C | pH | Buffer | Study duration | Polysorbate / % (v/w) | Polysorbate |
|---|---|---|---|---|---|---|---|
| Borisov et al. (2015) (Borisov et al., 2015) | 1.5-10 | 40 | - | Water | 19 h 40 h |
0.004 | PS20 (quality not defined) |
| 1.5-10 | 40 | - | Water | 12.5 h 40 h |
0.004 | PS80 (quality not defined) | |
| Larson et al. (2020) (Larson et al., 2020) | 10 | 4 (After irradiation) |
- | Water | 6 h irradiation with λmax= 350 nm | 1 | PS80 (quality not defined) |
| Zhang et al. (2018) (Zhang et al., 2018) | 1.5 | 40 | 5.5 | 20 mM Na-AcOH, His, or His-AcOH | 12, 24, 36, 48, 60, 72 h | 0.02 | PS20 HP |
| 1.5 | 40 | 5.5 | 20 mM Na-AcOH, His, or His-AcOH with either 10 mM L-His or imidazole or His methyl ester |
24 h | 0.02 | PS20 HP | |
| 4.5 | 40 | 5.5 | 20 mM Na-AcOH, His, or His-AcOH with either 10 mM L-His or imidazole or His methyl ester |
8 h | 0.02 | PS20 HP | |
| 9.0 | 40 | 5.5 | 20 mM Na-AcOH, His, or His-AcOH with either 10 mM L-His or imidazole or His methyl ester |
4 h | 0.02 | PS20 HP | |
| Zhang et al. (2017) (Zhang et al., 2017) | 1.5 | 40 | 1 7 11 |
Water | 12, 24, 36, 48 h | 0.1 | PS20 AL |
| Schröter et al. (2020) (Schröter et al., 2021) | 1.5 | 40 | Acidic | Water + trifluoroacetic acid (0.5 mM) | 5 w | 10 | PS80 (no BHT, 1 mM BHT, 0.3 mM BHT) |
| Peters et al. (2022) (Peters et al., 2022) | 0-1 | 5 / 25 / 40 | 5.5 6.0 |
20 mM L-His 20 mM phosphate 0-4.5 μM α-tocopherol |
1 m | 0.2 | PS80 (quality not defined) |