Recombinant Human Insulin-Like Growth Factor I

(rHuIGF-I)

Certificate of Analysis and Data Sheet

Description: Recombinant Human IGF-I produced in E.Coli is a single, non-glycosylated, polypeptide chain containing 70 amino acids and having a molecular mass of 7655 Dalton. rHuIGF-I is purified by proprietary chromatographic techniques.

Source: Escherichia Coli.

Physical Appearance:Sterile Filtered White lyophilized (freeze-dried) powder.

Formulation & Packaging: The protein was lyophilized after extensive dialysis against 50mM acetic acid.

Solubility: The lyophilized rHuIGF-I is very soluble in water and most aqueous buffers below and above the isoelectric point (pI=7.6).

 Stability: Lyophilized rHuIGF-I, although stable at room temperature, should be stored desiccated below 0°C. Reconstituted rHuIGF-Iis best stored refrigerated at 4°C.

Purity: Greater than 99.0%  as determined by:

(a) Analysis by RP-HPLC 

(b) Anion-exchange FPLC.

(c) Analysis by reducing and non-reducing SDS-PAGE Silver Stained 

(Limit of acceptance:³98.0%. No more than 2% total impurities; no single impurity greater than 1%)

Amino Acid Composition: In total agreement with the expected amino acid composition of native 
human IGF-I.

Amino acid sequence: The sequence of the first five N-terminal amino acids was determined and was found to be Gly-Pro-Glu-Thr-Leu, conforming the sequence of native human IGF-I. N-terminal methionine has been completely removed enzymatically.

Dimers and aggregates: Less than 1% as determined by silver-stained SDS-PAGE gel analysis.

Biological Activity: Our rHuIGF-I is fully biologically active when compared to standards. The ED50, calculated by the dose-dependant proliferation of murine BALB\C 3T3 cells (measured by 3H-thymidine uptake) is 1.0 ng/ml, corresponding to a specific activity of 1x106 U/mg. For most in-vitro applications, IGF-I exerts its biological activity in the concentration range of 0.2-20 ng/ml.

Endotoxin: Less than 0.1 ng/µg (IEU/µg) of rHuIGF-I.

Protein content: Protein quantitation was carried out by two independent methods: 

1.   UV spectroscopy at 280 nm using the absorbency value of 0.502 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 IGF-I as a Reference Standard.

Usage: This material is offered for research, laboratory or further manufacturing purposes.

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