Table 6C.

Overview of published stress studies related to polysorbate degradation using light. Light conditions, temperature, pH, buffer conditions, study duration, polysorbate concentration, and polysorbate quality are summarized. Abbreviations: His: histidine, d: day, w: week, AcOH: acetate.

Study	Light	Temperature / °C	pH	Buffer	Study /irradiation duration	Polysorbate / % (v/w)	Polysorbate
Ha et al. (2002) (Ha et al., 2002)	4951 lux Fluorescent light box Model BL1012, visible light a	40, 50, 60	-	Water	8 w irradiation	Neat 20	PS80 MC
Doyle et al. (2019) (Doyle et al., 2019)	300-800 nm according to 20, 50, 100 % ICH Q1B SUNTEST XLS + light chamber	50 (After irradiation)	5.5	10 mM His, citrate, phosphate	35 d (After irradiation)	0.02	PS80 MC
Agarkhed et al. (2012) (Agarkhed et al., 2013)	1.2 × 106 lxh, 200 Wh/m2 of near UV a Caron 6500 photostability chamber	25	6.0	10 mM His, NaCl, glycine, 5 mg·mL-1 mAb	-	0-1.0	PS80 (SR, NF, ultrapure)
Prajapati et al. (2022) (Prajapati et al., 2022)	UV light (ICH Q1B) 6.3-21 Wh/m2 λmax=350 nm 350-416 nm emission spectrum	-	6.0	Water, 10 mM citrate, 1 μM Fe3+Cl3	0-200 min irradiation	0.02	PS80 MC/AO
	Visible light 14-57 Wh/m2 λmax=419 nm 390-475 nm emission spectrum
Prajapati et al. (2020) (Prajapati et al., 2020)	<40 Wh/m2 for 1 h photoirr. at λ=254 nm; <25 Wh/m2 for 1 h photoirr. at λmax = 305, 350 and 419 nm	-	5.5	20 mM or 50 mM NaAcOH	1 h irradiation	0.01	PS80 (quality not defined)
						0.2
Larson et al. (2020) (Larson et al., 2020)	Rayonet system, 4 phosphor-coated low-pressure mercury lamps, λmax= 350 nm	4 (After irradiation)	-	Water, 10 mM AAPH	6 h irradiation with λmax=350 nm	1	PS80 (quality not defined)
Singh et al. (2012)	Caron 6500 series photostability chamber 1.2 × 106 luxh and 200 W hour m-2 of near UV light	25	6.5	10 mM histidine buffer + NaCl and glycine	6 d of irradiation	0.01	PS80, SR, NF, NOF (ultra-pure), another NF grade
				5 mg·mL-1 mAb

^ano specifications of the used wavelength