Recombinant Human GM-CSF
| Test | Specifications | Results |
| Identification | Positive | Positive |
| Appearance | Looks like a white to off-white crisp cake. After reconstitution, the solution is clear, colorless | Complies |
| Visible particles | Free of visible foreign particles | Complies |
| Sub-visible particles | ≥ 10µm: ≤ 6000/vial ≥ 25µm: ≤ 600/vial |
48 6 |
| Mass Variation | Complies to EP 6th | Complies |
| PH | 6.50 – 7.50 | 7.11 |
| Moisture | ≤ 3.0% | 0.6% |
| Potency | 80% – 150% ( 2.64-4.95x106IU/vial) |
105% (3.46x106IU/vial) |
| Sterility | Sterile | Sterile |
| Abnormal Toxicity Test | Complies to EP 6th /CP 2005 | Complies |
| Pyrogen Test (Rabbit) | Complies to EP 6th | Complies |
| Bacterial Endotoxins | Not more than 0.25 EU/vial | Less than 0.25 EU/vial |
| Conclusion | Complies | Complies |
BSE/TSE Declaration: GENTAUR BVBA manufactures GMP recombinant human GM-CSF (rHuGM-CSF-300) products under GMP controls and certifies that the entire product line is BSE (Bovine Spongiform Encephalopathy) and TSE (Transmissible Spongiform Encephalopathy) free. GENTAUR BVBA manufactures its products in Belgium.
Reconstitution: use 3000µl water for injection