Filling Process and Extractable Volume Test Method Variabilities. 95% Confidence Intervals Are Reported into Parentheses
| Vial Neck Diameter | ||
|---|---|---|
| 13 mm | 20 mm | |
| Relative average filling bias (RBfilling, %) | 0.68 (0.47–0.84) | 0.44 (0.32–0.54) |
| Relative filling precision (RSDfilling, %) | 1.23 (1.17–1.29) | 0.47 (0.45–0.50) |
| Relative extractable volume test method variability (RSDanalysis, %) | 23.56 (19.93–28.80) | |