Quantity: 300 µg
Code: rHuGM-CSF-300
Batch: 201007A10
Storage: 2 – 8 °C
Exp.Date: 14/07/2013
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.