CERTIFICATE OF ANALYSIS
Recombinant Human GM-CSF
rHuGM-CSF 300µg/vial
Batch No.:20050113Exp.Date:2008/01/13
Code: 04-RHUGM-CSF-20050113
Source:A DNA sequence encoding the mature human GM-CSF protein sequence was expressed in E. coli.
Molecular Mass:The 127 amino acid residue recombinant protein has a predicted molecular mass of approximately 14.5kD.
Purity: > 97%, as determined by SDS-PAGE and HPLC method.
Endotoxin Level: < 10EU/0.3mg of the cytokine as determined by the LAL method.
Activity: Measured in a cell proliferation assay using the factor-dependent cell line, TF-1, the specific activity shall be not less than 1×10**7IRU/mg.
Formulation: Lyophilized from a 0.2µm filtered solution in PBS containing 50µg of human serum albumin per 1µg of cytokine.
Reconstitution :It is recommended that sterile ddH2O containing at least 0.1% human serum albumin or bovine serum albumin be added to the vial to prepare a stock solution of no less than 1 µg/mL of the cytokine.
Storage: Lyophilized samples are stable for greater than six months from date of receipt at -20℃ to -70℃
Upon reconstitution, this cytokine can be stored under sterile conditions at 2- 8 for one month or at -20℃ to -70 ℃ in a manualdefrost freezer for three months without detectable loss of activity.