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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. |
|