Physicochemical Stability Study of Oral Suspension Containing Ruxolitinib in Children with Steroid-Refractory Acute Graft-Versus-Host Disease

Table 3

Stability of ruxolitinib phosphate 2 mg/mL oral solution stored at 22–25°C and 2–8°C for 60 days.

Storage	% ruxolitinib concentration remaining (mean ± SD) (n = 3)
	Initial concentration (mg/mL); Day 0	Day 5	Day 15	Day 21	Day 28	Day 36	Day 42	Day 60
22–25°C	2.08 ± 0.01	100.2 ± 0.6	100.9 ± 1.8	100.6 ± 1.1	100.8 ± 0.5	99.5 ± 0.8	97.8 ± 1.5	96.6 ± 0.5
2–8°C	2.07 ± 0.02	100.9 ± 1.9	101.8 ± 1.5	101.2 ± 1.2	99.2 ± 1.4	99.1 ± 1.8	100.6 ± 1.1	99.4 ± 0.6
Storage	pH value (mean ± SD) (n = 3)
	Day 0	Day 5	Day 15	Day 21	Day 28	Day 36	Day 42	Day 60
22–25°C	4.49 ± 0.01	4.45 ± 0.02	4.44 ± 0.01	4.44 ± 0.01	4.40 ± 0.01	4.40 ± 0.02	4.39 ± 0.01	4.36 ± 0.01
2–8°C	4.48 ± 0.01	4.47 ± 0.01	4.47 ± 0.01	4.44 ± 0.02	4.43 ± 0.01	4.42 ± 0.02	4.39 ± 0.01	4.36 ± 0.01

(one-way ANOVA).