Somatogen Recombinant Human Growth hormone (HGH) 100IU 10ML


Recombinant Human Growth hormone (hGH)


A DNA sequence encoding the mature hGH protein was expressed in P. Pastoris


0.2 μm-filtered solution in 20mM glycine, 200mM Mannitol, 20mM NaH2PO4 , pH 7.4; m-cresol 2mg/ml, glycerol 4 mg/ml

Protein concentration per 1ml:

3.3 mg ±4%

Release Testing: Specification Lot Result
Specific Activity 3.4 IU/mg 3.0-5 IU/mg
Purity: ≥ 97% >98.5%
Identity: Complies Complies
Sterility: Sterile Complies
Endotoxin level: <20 EU/mg <10 EU/mg
Host-cell DNA: ≤ 200ng/mg Complies (1.1ng/mg)

Activity was determined using a Nb2-11 cell proliferation assay

Purity was determined by SDS PAGE and coomassie stain (under reducing and non-reducing conditions). Identity was confirmed by end-of-production DNA sequencing and N-terminal protein sequencing. Sterility test of vialed product was performed according to Eur.Pharm. (Inoculation method).
Endotoxin was determined using the gel clot assay according to Eur.Pharm.
Host-cell DNA was determined using fluorimetric assay.

Handling Instructions:

General usage:

Open cap, clean the rubber stopper with disinfectant napkin or other cleaning disinfection method / material. Puncture rubber stopper with sterile needle and draw the ready to use product (see below) into sterile syringe according doctor instructions.

Using liquid product:

Liquid product is ready to use according doctor instructions

Dilution for ex vivo procedures:

Recommended in CellGro®/CellGenixTM serum free media. For dilution with PBS or protein free medium a carrier protein (0.1-1% albumin or 1-10% appropriate serum) has to be included. Failure to dilute product according to these instructions will result in loss of activity.

Storage and stability:

Store material at +4 – +8C0, do not freeze. Store diluted material for ex vivo use at +40C. Do not freeze!

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