Table 1. Particle size distribution obtained by multiple techniques: cumulant analysis and distribution analysis by batch mode DLS; mean, mode, minimum and maximum diameters obtained by online MALS (Dg by Zimm model) and online DLS (Dh by cumulant analysis) PSD. Mean, mode and D10, D50 and D90 obtained by number based-PSD measured by TEM and PTA.
| Batch
mode DLS (Dh in nm) |
AF4-MALS
(Dg in nm) |
AF4-DLS
(Dh in nm) |
TEM
(Diameter of an equivalent sphere in nm) |
PTA
(Dh in nm) |
||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cumulant
analysis |
PSD
analysis (Intensity based PSD) |
Mass
based PSD |
Intensity
based PSD |
Number
based PSD |
||||||||||||
| Sample | z-avea (SD) | PdIa (SD) | Pk1-Inta (σ) | % of peak area | Modeb | Meanc(SD) | Dmin, Dmax | Modeb | Meanc (SD) | Dmin, Dmax | Moded | Meand | D10, D50, D90 | Mode | Mean | D10, D50, D90 |
| Naked Lipidots | 54 (1) | 0.142 (0.005) | 62 (26) | 100 | 35 | 43 (3) | 24, 60 | 42 | 48 (2) | 30, 70 | 21 | 29 | 14, 24, 45 | 45 | 56 | 32, 43, 67 |
| Naked Lipidots in serum | 41 (2) | 0.279 (0.003) | 61 (28) | 93 | 37 | 38 (3) | 32, 43 | 40 | 44 (2) | 40, 56 | 25 | 28 | 18, 27, 36 | NAe | NA | NA |
| Lipimage815 | 51 (1) | 0.139 (0.018) | 60 (24) | 100 | 24 | 33 (4) | 10, 52 | 40 | 43 (4) | 27, 67 | 29 | 32 | 21, 29, 45 | 47 | 65 | 36, 46, 104 |
| Lipimage815 in serum | 40 (1) | 0.281 (0.003) | 61 (30) | 93 | 38 | 40 (4) | 36, 45 | 40 | 45 (4) | 38, 56 | 25 | 29 | 17, 25, 41 | NA | NA | NA |
| ICG Lipidots | 52 (1) | 0.138 (0.006) | 61 (25) | 100 | 31 | 37 (4) | 17, 59 | 40 | 48 (4) | 22, 70 | 21 | 29 | 12, 24, 44 | NA | NA | NA |
| ICG Lipidots in serum | 42 (1) | 0.258 (0.03) | 60 (26) | 94 | 44 | 42 (4) | 40, 46 | 50 | 52 (4) | 40, 66 | 20 | 26 | 11, 21, 41 | NA | NA | NA |
a
Mean and standard deviation of the z-ave and PdI means calculated over 10 replicates; σ = standard deviation of the PSD by intensity, representative of the distribution with:
b
Value of the diameter calculated at the fractogram maximum (UV–vis detector).
c
Mean and standard deviation of the mean over 3 replicates. The mean values are values calculated by averaging the diameter over the fwhm of one elution peak as indicated by the ISO/TS 21362:2018.
d
Mode value estimated by fitting the PSD number by a LogNormal distribution.
e
NA= not available