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Somatropin (rHuGH)

 

 

l        Description

Recombinant Human Growth Hormone is a sterile protein product for injection. rHuGH is produced by recombinant DNA technology by Yeast. It is a highly purified protein containing 191 amino acids, and has a molecular weight of approximately 22.1kD. Its amino acid sequence is identical to that of human growth hormone of pituitary origin.

 

l        Indication

1. Indicated for the growth failure of children due to endogenous growth hormone deficiency (GHD), chronic renal insufficiency (CRI) and Turner's syndrome.

2. Indicated for severe burn.

 

 

l        Pharmaceutical particulars

Sterile, white and preservative-free lyophilized powder to be reconstituted with a diluent (Sterile Water for Injection) for injection, presented in vials.

Dosage: 4 IU/vial

Reference: Current European Pharmacopoeia

Specific activity: ≥2.8 IU/mg

Purity (HPLC, SDS-PAGE): ≥98%

 

l        Composition

Active ingredient: Recombinant Human Growth Hormone (rHuGH)

Inactive ingredients: Mannitol, Glycine, Dibasic Sodium Phosphate and Monobasic Sodium Phosphate.

 

l        Shelf life and storage conditions

 

 Finished formulation  Store at 2-8 for 2 years
 API (Concentrated solution)  Store at -70 for 12 months
 

 

 

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Last modified: 05/19/16