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

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