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Robustness and stability.
| Robustness (%RSD, n = 3) | Solution Stability (% Difference, n = 3) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Column Temp. (40 ± 4 °C) | Flow Rate (0.3 ± 0.03 mL/min) | Standard Solution | In Drug Substance | In Drug Product | |||||
| Area | RT | Area | RT | 9 h | 18 h | 9 h | 18 h | 9 h | 18 h |
| 2.60 | 1.49 | 4.00 | 3.59 | −6.44 | −2.97 | −5.76 | 6.87 | 0.51 | 5.17 |
