rHu G-CSF

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Recombinant Human Granulocyte-Colony Stimulating Factor

Concentrated Solution

Formulation: rHu G-CSF, Sodium Acetate 10 mM, Tween 80 0.04 mg/ml, pH 4.0-4.5.

Purity and Identification: SDS-PAGE (reducing): not more than 3% contaminants.

SDS-PAGE (non-reducing): not more than 3% contaminants in the oligomeric region.

HPLC: principal peak >95%

Western blot specific antibody identification.

Absence of host cell derived proteins: less than 0.6%; and host cell derived DNA (dot blot hybridization): less than 100 pg per 480 ug of protein. Technical Reports Series N°747-WHO.

Sterility Test: USP XXVII

Safety Test: USP XXVII

Endotoxin level: <100 EU per mg of protein. (LAL test).
Biological Activity: Determined on a cell proliferation assay using an AML cell line, (Santoli D et al. J. of Immunol. 1987 139: 3348-3354)

Specific activity: Not less than 40 x 106 IU per mg, and not more than 160 x 106 IU per mg of protein, according to lot #.

Molecular Mass: 18,300 +/- 1,000 Da

Source: E. coli

For research use only. Not for use in diagnostics or therapeutic procedures

• Cell proliferation assay using an AML cell line, (Santoli D et al. J. of Immunol. 1987 139: 3348-3354)

• Analyzed on Graph Pad Prism 4 software