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Interleukin 2 (IL-2)
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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.
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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.
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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%
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Composition
Active
ingredient: Recombinant Human Interleukin 2 (rHuIL-2)
Inactive
ingredients:
Glacial Acetic Acid, Mannitol, Polysorbate-80 and Sodium Acetate.
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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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1641 4407
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