. 2023 Jul 27;6:100202. doi: 10.1016/j.ijpx.2023.100202

Table 6E.

Overview of published stress studies of polysorbate degradation in the presence of H₂O₂. H₂O₂ concentration, temperature, pH, buffer conditions, study duration, polysorbate concentration, and polysorbate quality are summarized. Abbreviations: His: histidine, d: day, w: week, MC: multicompendial, AO: all-oleate, AL: all-laurate, AcOH: acetate, BHT: butylated hydroxytoluene.

Study	H₂O₂ / mM	Temperature / °C	pH	Buffer	Study duration	Polysorbate / % (v/w)	Polysorbate
Kranz et al. (2019) (Kranz et al., 2019)	1 10	40	6.0	10 mM His, 8 % (w/v) sucrose	17 d	0.04	PS20 MC PS80 MC/AO
Kranz et al. (2019) (Kranz et al., 2019)	1 10	40	5.5	10 mM AcOH, 8 % (w/v) sucrose	17 d	0.04	PS20 MC/AL PS80 MC/AO
Kishore et al. (2011) (Kishore et al., 2011a)	8.8	80	6.0	20 mM His, 10 mg·mL^-1 mAb2, 240 mM trehalose	7 d	0.02	PS20 (quality not defined) PS80 (quality not defined)
Kishore et al. (2011) (Kishore et al., 2011a)	8.8	80	6.0	20 mM His, 10 mg·mL^-1 mAb2, 240 mM trehalose	7 d	0.005-0.03	PS20 (quality not defined) PS80 (quality not defined)
Schröter et al. (2020) (Schröter et al., 2021)	10	RT	Acidic	Water + trifluoroacetic acid (0.5 mM), 0.1 mM Fe²⁺SO₄	5 w	10	PS80 (no BHT, 1 mM BHT, 0.3 mM BHT)