Growth Hormone 1, commonly referred to as Human Growth Hormone (HGH) or Somatropin, is a recombinant protein hormone structurally equivalent to naturally occurring human growth hormone. It is produced using recombinant DNA technology and is used therapeutically for selected growth hormone deficiency and growth-related disorders.
Growth hormone is a 191-amino-acid single-chain polypeptide with important effects on growth, protein synthesis, carbohydrate metabolism and lipid metabolism.
Growth Hormone 1 is a specialized recombinant biological pharmaceutical API. Its manufacturing requires controlled expression in a suitable host system, purification, refolding where applicable and extensive analytical characterization.
Unlike conventional small-molecule APIs, growth hormone quality is evaluated using protein-specific analytical methods including peptide mapping, purity, aggregation, biological potency and host-cell impurity testing.
Product Name: Growth Hormone 1
Common Name: Human Growth Hormone / Somatropin
Molecule Type: Recombinant protein hormone
Protein Length: 191 amino acids
Drug Class: Growth Hormone
Therapeutic Class: Endocrine Hormone
Therapeutic Area: Endocrinology / Growth Disorders
Growth hormone binds to the growth hormone receptor (GHR) on target cells. Receptor activation stimulates intracellular signaling, particularly the JAK2–STAT pathway, leading to changes in gene expression.
Growth hormone also stimulates production of insulin-like growth factor-1 (IGF-1), which contributes substantially to linear bone growth and other anabolic effects.
Recombinant human growth hormone is used in approved indications involving growth hormone deficiency and certain pediatric and adult growth-related disorders. Specific indications depend on the approved product labeling and regulatory jurisdiction.
Growth hormone promotes growth of bone and other tissues and supports normal protein synthesis. In children with appropriately diagnosed growth hormone deficiency, replacement therapy can help restore growth toward the individual's expected growth potential.
Human growth hormone is a 191-amino-acid recombinant polypeptide containing two intramolecular disulfide bonds. It has a molecular mass of approximately 22 kDa.
As a biological protein, it does not have the type of conventional small-molecule specification profile used for chemical APIs. Identity, purity, structural integrity and biological activity are particularly important quality attributes.
Growth Hormone 1 API quality evaluation may include:
Growth Hormone 1 should be maintained under validated, controlled storage conditions appropriate for a recombinant protein. Protection from excessive temperature, light and conditions that may cause protein degradation is important. Exact storage requirements should follow the validated stability program and product-specific specification.
Growth Hormone 1 is an established recombinant protein used in endocrine pharmaceutical development and growth hormone replacement therapy. Its biological characterization is based on structural integrity, purity and receptor-mediated biological activity.
Growth Hormone 1, commonly known as human growth hormone or somatropin, is a recombinant 191-amino-acid protein hormone with an approximate molecular mass of 22 kDa. It acts through the growth hormone receptor and IGF-1 pathway and is used therapeutically for selected growth hormone deficiency and growth-related conditions.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 90.0% – 110.0% of labeled/reference value |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 6.0 – 7.5 |
| Water Content | ≤5.0% |