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


Specifications and Use

Description
 Recombinant human IFN a-2a 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 19.2kD.

Source
 Yeast

Molecular Mass
 Approximately 19.2kD.

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

Endotoxin Level
 ≤1EU/µg, determined by the LAL method.

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

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 not less than 1 mg/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 manual defrost freezer for three months without detectable loss of activity.
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

 

91

5

 

Mass Variation

Complies to EP 5th

Complies

pH

4.50 – 5.50

4.99

Potency

80% - 150% of stated value

(2.40 –4.50 x 106IU/vial)

111%

(3.34 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