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. Author manuscript; available in PMC: 2019 Jul 1.
Published in final edited form as: J Pharm Sci. 2018 Mar 27;107(7):1852–1857. doi: 10.1016/j.xphs.2018.03.016

Table 2.

Concentrations for particles of sizes between 60-1000 nm (108/mL) in IVIG solution centrifuged at various g forces and incubated at either 25° C or at 50° C

45 minutes @2,350g 45 minutes @30,000g 3 hours @112,000g
Incubation at 25° C
Day 0 0.64 0.29
Day 1 0.32 ± 0.15 1.96 ± 1.15
Day 2 n/aa 0.29 ± 0.27 1.93 ± 1.13
Day 3 0.42 ± 0.19 0.63 ± 0.22
Day 4 0.55 ±0.10 1.33 ± 0.62
Day 5 1.76 ± 2.10 1.18 ±0.41
Incubation at 50° C
Day 0 4.1 1.28
Day 1 4.49 ± 0.27 0.71 ± 0.26
Day 2 n/aa 4.19 ± 1.59 1.02 ± 0.68
Day 3 2.35 ± 2.28 0.37 ± 0.14
Day 4 1.90 ± 0.24 0.08 ± 0.06
Day 5 1.80 ± 0.82 0.76 ± 0.48
*

Measurement error represents standard deviation from measurement of three independent samples

a

Particle levels above the upper limit of quantitation of the instrument (ca 109 particles/mL)