Recombinant Human Growth Hormone-20K

(rHuGH-20K)

Certificate of Analysis and Data Sheet

 

       ×         Description:

Recombinant Human GH-20K produced in E.Coli is a single, non-glycosylated,

          polypeptide chain containing 177 amino acids and having a molecular mass of

          20322 Dalton.    

          rHuGH-20K is purified by proprietary chromatographic techniques.

 

       ×         Source:

Escherichia Coli.

 

       ×         Physical Appearance:

Sterile Filtered White lyophilized (freeze-dried) powder.

 

       ×         Formulation & Packaging:

The protein was lyophilized from a concentrated (1mg/ml) solution with 0.0045mM NaHCO3.

 

       ×         Solubility:

The lyophilized rHuGH-20K is very soluble in water and most aqueous buffers above the isoelectric point (pI=5.25). It is recommended to reconstitute at pH=10.5.

 

       ×         Stability:

Lyophilized rHuPGH-20K although stable at room temperature, should be stored desiccated below 0°C. Reconstituted rHuGH-20K  is best stored refrigerated at 4°C.

 

       ×         Purity:

Greater than 98.0% 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 GH-20K.

 

       ×         Amino acid sequence:

The sequence of the first five N-terminal amino acids was determined and was found to be Met-Ala-Thr-Gly-Ser, conforming to the sequence of native human GH-20K.

 

       ×         Dimers and aggregates:

Less than 1% as determined by silver-stained SDS-PAGE gel analysis.

 

       ×         Biological Activity:

Our rHuGH-20K is fully biologically active when compared to World Health Organization (WHO) reference standard.

 

       ×         Endotoxin:

Less than 0.1 ng/µg (IEU/µg) of rHuGH-20K.

 

       ×         Protein content:

          Protein quantitation was carried out by two independent methods:

 

1.      UV spectroscopy at 280 nm using the absorbency value of 0.73 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 GH-20K as a Reference Standard.

 

      ×        Usage:

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