Table III.
Comparison of Protein-Like Particles and Silicone Oil Droplet-Like Particle Concentrations (Particles/ml) in Some Filgrastim Products Measured by MFI
| Trade name | Size range [μm] | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Protein-like particles [particles/ml] | Silicone oil droplet-like particles [particles/ml] | ||||||||||
| ≥1 | ≥2 | ≥5 | ≥10 | ≥25 | ≥1 | ≥2 | ≥5 | ≥10 | ≥25 | ||
| Neupogen | 60,369 | 18,244 | 764 | 92 | 4 | 17,724 | 25,123 | 4945 | 363 | 11 | |
| Tevagrastim | 27,439 | 4276 | 237 | 38 | 4 | 6932 | 3638 | 397 | 57 | 4 | |
| Biocilin | 8021 | 546 | 23 | 8 | 0 | 2182 | 413 | 8 | 0 | 0 | |
| Neupogen | A | 9260 | 944 | 57 | 8 | 4 | 2797 | 1620 | 134 | 4 | 0 |
| B | 15,557 | 1972 | 164 | 69 | 0 | 6722 | 3183 | 88 | 11 | 0 | |
| E | 19,440 | 1525 | 103 | 27 | 0 | 6168 | 2174 | 118 | 0 | 0 | |
| F | 20,873 | 1204 | 99 | 11 | 8 | 6199 | 1380 | 88 | 19 | 4 | |