Certificate of Analysis & Data Sheet
IFN-alpha is produced by macrophages and has antiviral activities. Interferon stimulates the production of two enzymes: protein kinase and an oligoadenylate synthetase. Recombinant human interferon alpha 2A is produced in E.Coli as a single, non-glycosylated, polypeptide chain containing 165 amino acids and having a molecular mass of 19241 Dalton according to the sequence of interferon-alpha 2A gene obtained from human leukocytes. The IFN-alpha 2A was purified by proprietary chromatographic techniques.
Sterile Filtered White lyophilized (freeze-dried) powder.
Lyophilized from (1mg/ml) solution containing 7.21 mg sodium chloride and 0.77 mg ammonium acetate per ml.
It is recommended to reconstitute the lyophilized Interferon-alpha 2A in sterile 18MΩ-cm H2O not less than 100µg/ml, which can then be further diluted to other aqueous solutions.
Lyophilized Interferon alpha 2A although stable sterile at room temperature for 3 weeks, should be stored desiccated below -18°C. Upon reconstitution IFN-alpha 2A should be stored at 4°C between 2-7 days and for future use below -18°C.
For long term storage it is recommended to add a carrier protein (0.1% HSA or BSA).
Please prevent freeze-thaw cycles.
Greater than 98.0% as determined by both:
(a) Analysis by RP-HPLC.
(b) Analysis by SDS-PAGE.
Amino Acid Sequence:
The sequence of the first five N-terminal amino acids was determined and was found to be Cys-Asp-Leu-Pro-Gln, conforming to the sequence of native human IFN-alpha. The N-terminal methionine has been completely removed enzymatically.
Dimers and Aggregates:
Over 95% monomers
The specific activity as determined in a viral resistance assay using bovine kidney MDBK cells was found to be 2.7 x 10E8 IU/mg.
Less than 0.1 ng/µg (IEU/µg) of INF-alpha 2A
Protein quantitation was carried out by two independent methods:
1. UV spectroscopy at 280 nm using the absorbency value of 0.924 as the extinction coefficient for a 0.1% (1mg/ml) solution. This value is calculated by the PC GENE computer analysis program of protein sequences (IntelliGenetics).
2. Analysis by RP-HPLC, using a calibrated solution of IFN-alpha 2A as a Reference Standard.
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