- 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.
- Indication
- Indicated for the treatment of adults with metastatic renal cell carcinoma (metastatic RCC).
- Indicated for the treatment of adults with metastatic melanoma.
- 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%
- Composition
Active ingredient: Recombinant Human Interleukin 2 (rHuIL-2)
Inactive ingredients: Glacial Acetic Acid, Mannitol, Polysorbate-80 and Sodium Acetate.
- 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 |