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Index / Gentaur / rHu IL 2 , 3MIU , Lot 200908F02 / Product Detail : 04-RHIL2-08F02 rHu IL 2 , 3MIU , Lot 200908F02
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Aug
28th

#04-RHIL2-08F02 rHu IL 2 , 3MIU , Lot 200908F02

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  Price : 254   EUR
289   USD
197   GBP
1069   Zloty
34067   JPY
1963   NOK
2103   SEK
287   CHF

Product name : rHu IL 2 , 3MIU , Lot 200908F02

Catalog number : 04-RHIL2-08F02

Quantity:

Availability: Yes

Supplier name : Gentaur

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More Details about

 

l  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.

 

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 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%

 

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

 

 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

 

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