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rHuIL-2-3MIU   GENTAUR HEADQUARTERS  +32 1641 4407  +32 1650 9045 

 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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Interleukin 2 (IL-2)

 

 

l        Description

Recombinant human interleukin-2 is a sterile protein product for injection. rHuIL-2 is produced by recombinant DNA technology by Yeast. It is a highly purified protein containing 133 amino acids, with cysteine mutated to alanine at 125 amino acid position, and has a molecular weight of approximately 15.4kD, non-glycosylated.

 

l        Indication

1.      Indicated for the treatment of adults with metastatic renal cell carcinoma (metastatic RCC).

2.      Indicated for the treatment of adults with metastatic melanoma.

 

l        Pharmaceutical particulars

Sterile, clear, colorless and preservative-free liquid for injection in vial.

Dosage: 3 million IU (0.3ml)/vial

Reference: Current Chinese Pharmacopoeia and Internal requirement

Specific activity: ≥3×107IU/mg

Purity (HPLC, SDS-PAGE): ≥98%

 

l        Composition

Active ingredient: Recombinant Human Interleukin 2 (rHuIL-2)

Inactive ingredients: Glacial Acetic Acid, Mannitol, Polysorbate-80 and Sodium Acetate.

 

l        Shelf life and storage conditions

 

 Finished formulation

 Store at 2-8 for 2 years
 API (Concentrated solution)  Store at -70 for 12 months

 

CERTIFICATE OF ANALYSIS

 

  

Tests

Specifications

Results

Identification (Immunoblot)

Positive

Positive

Appearance

Clear, colorless solution

Complies

Particulate Matter

 

 

         Visible particles

Free of Visible foreign particles

Complies

         Sub-visible particles

≥10µm: ≤6000/vial

≥25µm: ≤600/vial

 

291

7

 

Mass Variation

Complies to EP 5th

Complies

pH

4.00 – 5.00

4.69

Potency

80% - 150% of stated value

(2.40 – 4.50 x 106IU/vial)

116%

(3.48 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

 

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Last modified: 06/25/09