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    seal-in-search-symantec

     

     

    Wednesday, 22 May 2013 14:39

    rHu IL 2, 3MIU, Lot 200908F02

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    (1 Vote)
    1. Description

    Recombinant human interleukin-2 is a sterile protein product for injection. rHuIL-2 is produced by recombinant DNA technology using 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.

    1. 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.
    1. Pharmaceutical particulars

    Sterile, clear and colorless liquid for injection in vial.

    Dosage: 3 million IU (0.3ml)/vial

    Reference: Current CP/Internal

    Specific activity: ≥1.7×107IU/mg

    Purity (HPLC, SDS-PAGE): ≥98%

    1. Composition

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

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

    1. Shelf life and storage conditions

     

     Drug Product

     Storage at 2-8℃ for 2 years
     Drug Substance (Concentrated solution)  Storage at -70℃ for 12 months

     

     

    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

    162

    41

    Mass Variation

    Complies to EP 6th

    Complies

    pH

    4.00 – 5.00

    4.68

    Potency

    80% - 150% of stated value

    (2.40 – 4.50 x 106IU/vial)

    113%

    (3.40 x 106IU/vial)

    Sterility

    Sterile

    Sterile

    Abnormal Toxicity test

    Complies to EP 6th

    Complies

    Pyrogen Test (Rabbit)

    Complies to EP 6th

    Complies

    Bacterial Endotoxins

    Not more than 1 EU/ml

    Less than 1 EU/ml

    Conclusion

    Complies

    Complies

     

     

    Price: 209 EUR 

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