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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
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Tests |
Specifications |
Results |
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Identification (Immunoblot) |
Positive |
Positive |
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Appearance |
Clear, colorless solution |
Complies |
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Particulate Matter |
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Visible particles |
Free of Visible foreign paticles |
Complies |
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Sub-visible particles |
≥10µm: ≤6000/vial
≥25µm: ≤600/vial
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91
5
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Mass Variation |
Complies to EP 5th |
Complies |
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pH |
4.50 – 5.50 |
4.99 |
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Potency |
80% - 150% of stated value
(2.40 –4.50 x 106IU/vial) |
111%
(3.34 x 106IU/vial) |
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Sterility |
Sterile |
Sterile |
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Abnormal Toxicity test |
Complies to EP 5th |
Complies |
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Pyrogen Test (Rabbit) |
Complies to EP 5th |
Complies |
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Bacterial Endotoxins |
Not more than 1 EU/ml |
Less than 1 EU/ml |
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Conclusion |
Complies |
Complies |
FOR RESEARCH USE ONLY. NOT FOR HUMAN USE
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+32
1641 4407
+32 1650 9045 
