Table 4.
Stability data of trastuzumab signature peptide (IYPTNGYTR) after 6 h incubation at 4 °C in human serum batch. Mean ratio; 100.2% and 107.9% and % change; −5.9 and 13.9 was observed at HQC and LQC level, respectively. Here, n represents the number of samples analyzed for the stability experiment. (Acceptance criteria: %Change ≤15%; %Mean ratio 90%–110%, %CV ≤20%).
| Parameters | Freshly Injected | After 6.0 h | ||
|---|---|---|---|---|
| HQC (µg/mL) | LQC (µg/mL) | HQC (µg/mL) | LQC (µg/mL) | |
| Calculated concentration of signature peptide | 371.105 | 16.441 | 348.739 | 18.068 |
| 388.888 | 15.735 | 337.011 | 17.899 | |
| 383.461 | 12.462 | 378.322 | 16.052 | |
| 337.262 | 18.304 | 391.093 | 17.159 | |
| 381.139 | 15.744 | 414.900 | 17.195 | |
| 369.525 | 16.588 | 365.539 | 16.448 | |
| Mean | 371.8967 | 15.8790 | 372.6007 | 17.1368 |
| SD | 18.51309 | 1.91906 | 28.45981 | 0.78781 |
| Coefficient of Variability (CV) | 5.0 | 12.1 | 7.6 | 4.6 |
| Nominal Concentration (µg/mL) | 396 | 15.144 | 396 | 15.144 |
| N | 6 | 6 | 6 | 6 |
| % Change | −5.9 | 13.2 | ||
| % of Mean ratios | 100.2 | 107.9 | ||