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The predicted and determined CQAs of the formulation corresponding to the robust setpoint inside the design space for lyo-LCL-SIM.
| Response | Predicted | Min | Max | Actual |
|---|---|---|---|---|
| Size (nm) | 514.73 | 328.8 | 805.75 | 710.03 |
| Liposomal SIM concentration (µg/ml) | 271.72 | 165.4 | 377.97 | 288.9 |
| ESR (%) | 44.90 | 40.55 | 49.74 | 42.23 |
| Tm change (C) | −0.72 | −1.65 | 0.21 | −1.18 |
| Water content (%) | 2.87 | 2.16 | 3.58 | 3.15 |
