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.

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 5^th

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 5^th

Complies

Pyrogen Test (Rabbit)

Complies to EP 5^th

Complies

Bacterial Endotoxins

Not more than 1 EU/ml

Less than 1 EU/ml

Conclusion

Complies

Complies