HUV Determined for Parenteral Drug Product
| Parenteral Product | Container Configuration | Viscosity | HUV Limits at 95% Confidence Based on Linear Regression Model | Experimentally Determined HUV |
|---|---|---|---|---|
| mAb-1 | 2R vial and 1 mL disposable syringe | 9 cP | 0.098–0.126 mL | 0.105 mL |
| mAb-2 | 6R vial and 5 mL disposable syringe | 1.3 cP | 0.160–0.192 mL | 0.183 mL |
| mAb-3 | 10R vial and 10 mL disposable syringe | 1.4 cP | 0.182–0.236 mL | 0.213 mL |
| mAb-2 | 1 mL PFS | 1.3 cP | 0.003–0.006 mL | 0.005 mL |
| mAb-2 | 2.25 mL PFS | 1.3 cP | 0.003–0.008 mL | 0.007 mL |