Table 5.

Subvisible particle concentrations (ECD ≥ 2 μm) observed in the controls (DIUF water, buffer, 5 μm Count-Cal) and PS 8670

Samples	Particle Concentration ECD ≥ 2 μm (mL−1), n ≥ 3	CV (%)	Range of Concentration of Protein in Particles (ng/mL)	aRange of Protein in Particles/Protein in Solution (%)
DIUF water	12 (5)	–	–
Buffer	42 (32)
5 μm Count-Cal	2898 (32)	1
8670 n = 4 (2 days)	4271 (1413)	33	105 to 449	0.0013 to 0.0045

^aTotal protein concentrations from referenced UV absorbance values [29] were used to approximate the ratio of the concentration of protein in the particles to the concentration of protein in solution. The uncertainty is expressed as (SD)