Table 5.
Table demonstrates the stability data of trastuzumab signature peptide (IYPTNGYTR) after four freeze-thaw cycles of the human serum batch. Mean ratio; 100.0% and 104.0%and %change; −6.1 and 9.1 was observed at HQC and LQC level, respectively. Here, n represents the number of sample analyzed for the stability experiment. (Acceptance criteria: %Change ≤15%; % Mean ratio 90%–110%, %CV ≤20%).
| Parameters | Freshly Injected | After 4 FT CYCLE | ||
|---|---|---|---|---|
| HQC (µg/mL) | LQC (µg/mL) | HQC (µg/mL) | LQC (µg/mL) | |
| Calculated Concentration of signature peptide | 371.105 | 16.441 | 290.497 | 15.902 |
| 388.888 | 15.735 | 383.686 | 16.895 | |
| 383.461 | 12.462 | 414.378 | 16.081 | |
| 337.262 | 18.304 | 408.799 | 17.457 | |
| 381.139 | 15.744 | 427.938 | 16.552 | |
| 369.525 | 16.588 | 305.989 | 16.244 | |
| Mean | 371.8967 | 15.8790 | 371.8812 | 16.5218 |
| SD | 18.51309 | 1.91906 | 59.01829 | 0.57800 |
| CV | 5.0 | 12.1 | 15.9 | 3.5 |
| Nominal value (µg/mL) | 396 | 15.144 | 396 | 15.144 |
| N | 6 | 6 | 6 | 6 |
| % Change | −6.1 | 9.1 | ||
| % of Mean ratios | 100.0 | 104.0 | ||