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 rHuIL-2-3MIU huIFNa-2a huIFNa-2b Mouse GM-CSF rHuIL-4 GMPhuIL-4-50µg RHUGMCSF-300µg RHUGM-CSF-50µg huG-CSF-300µg huIL-6 -50 µg rhug-csf 300µg rhug-csf_75µg rhuil-1b-100µg

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Recombinant Human Interferon a-2b (rHuIFNa-2b )

 

 

 

 

Specifications and Use

 

Description

 

l          Recombinant human IFN a-2b produced in Yeast is a single, non-glycosylated, polypeptide chain containing 165 amino acids, two pairs of disulfide bonds and having a molecular mass of approximately 19.3kD.

 

Source

l          Yeast

 

Molecular Mass

 

l        Approximately 19.3kD.

 

Purity

 

l          97%, as determined by SDS-PAGE and HPLC method.

Endotoxin Level

 

l          1EU/µg, determined by the LAL method.

Biological Activity

l         Bioactivity is detected using cytopathic effect inhibition assay method, WISH cell (a heteroploid human amnion cell line) as dependent cell strain. The specific activity shall be not less than 2.0×108 IU/mg.
 

Formulation

 

l          Lyophilized from a 0.2μm filtered solution in 20mM Phosphate buffer.

 

Reconstitution

l          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 not less than 1 mg/mL of the cytokine.

 

Storage

 

l          Lyophilized samples are stable for greater than six months from date of receipt at -20 to -70.

l          Upon reconstitution, this cytokine can be stored under sterile conditions at 2- 8℃ for one month or at -20℃ to -70℃ in a manual defrost freezer for three months without detectable loss of activity.

l          Avoid repeated freeze-thaw cycles.

 

 

   

CERTIFICATE OF ANALYSIS

 

  

Tests

Specifications

Results

Identification (Immunoblot)

Positive

Positive

Appearance

Clear, colorless solution

Complies

Particulate Matter

 

 

         Visible particles

Free of Visible foreign paticles

Complies

         Sub-visible particles

≥10µm: ≤6000/vial

≥25µm: ≤600/vial

 

179

7

 

Mass Variation

Complies to EP 5th

Complies

pH

6.50 – 7.50

6.87

Potency

80% - 150% of stated value

(2.40 –4.50 x 106IU/vial)

109%

(3.28 x 106IU/vial)

Sterility

Sterile

Sterile

Abnormal Toxicity test

Complies to EP 5th

Complies

Pyrogen Test (Rabbit)

Complies to EP 5th

Complies

Bacterial Endotoxins

Not more than 1 EU/ml

Less than 1 EU/ml

Conclusion

Complies

Complies

 

    FOR RESEARCH USE ONLY. NOT FOR HUMAN USE.  

 

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Last modified: 06/25/09