Table 1.
Intermediate precision of optimized CE-SDS assay
| Parameter | Mean ± uca | CV |
|---|---|---|
| Instrument Qualification (IQ) Standard | ||
| 10 kDa internal standard migration time (min) | 12.45 ± 0.12 | 1.0% |
| 100 kDa marker migration time (min) | 21.97 ± 0.21 | 1.0% |
| PS 8670 | ||
| Monomer migration time (min)b | 28.19 ± 0.28 | 1.0% |
| Monomeric purity (%)b | 98.79 ± 0.38 | 0.4% |
| Light chain migration time (min)c | 15.29 ± 0.18 | 1.2% |
| Heavy chain migration time (min) c | 19.29 ± 0.23 | 1.2% |
| Light chain relative abundance (%) | 32.02 ± 0.20 | 0.6% |
| Heavy chain relative abundance (%) | 67.26 ± 0.20 | 0.3% |
| Glycan occupancy (%)c | 99.40 ± 0.01 | 0.01% |
| NRS relative abundance (%)c | 0.31 ± 0.02 | 4.9% |
aStated uncertainty represents the intermediate precision reported as a combined standard uncertainty, at a level of one standard deviation, based on ANOVA analysis as described in ESM(n = 12)
bnon-reduced sample
creduced sample