Recombinant Human GM-CSF - 300 ug

Identification (Immunodot): Positive reaction with anti-hGM-CSF antibody

Appearance: White to off-white crisp cake. After reconstitution, the solution is clear

Particulate Matter - Visible particles: Not more than the pre-determined limit

Matter - Sub-visible particles: ≥ 10µm: ≤ 6000/vial - ≥ 25µm: ≤ 600/vial

Mass Variation: 2.0% (Acceptance value ≤ 10.0%)

pH: 7.0 (6.5 – 7.5)

Water: 0.8% (≤ 3.0%)

Osmolality: 318 mOsmol/kg (250-370 mOsmol/kg)

Residual Antibiotic Activity: No residual antibiotic activity detected

Potency: 120% (3.96x 10^6 IU/vial) [80% - 150% ( 2.64x10^6- 4.95 x 10^6 IU/vial)]

Sterility: Sterile

Abnormal Toxicity: None of the mice shows any abnormal signs during the observation period

Pyrogen (Rabbit): Summed response of rabbits does not exceed the specified temperature

Bacterial Endotoxins: < 0.25 EU/vial