Tesamorelin is a synthetic peptide analogue of human growth hormone-releasing factor (GHRF/GHRH). It is a 44-amino-acid modified peptide designed to stimulate the growth hormone-releasing factor receptor and promote the physiological release of growth hormone. Tesamorelin is supplied as a pharmaceutical peptide API and is commonly characterized in its acetate-associated form.
Tesamorelin has the molecular formula C221H366N72O67S and a molecular weight of approximately 5135.9 Da for the free peptide. The acetate-associated drug substance is described by regulatory sources as tesamorelin acetate.
Tesamorelin is a stabilized synthetic analogue of human GHRH containing 44 amino acids. The peptide incorporates a hexenoyl modification at the N-terminal tyrosine residue, which contributes to its structural and pharmacological properties.
The API is characterized using peptide-specific analytical techniques including reverse-phase HPLC/UPLC, mass spectrometry, peptide identity testing, related-substance profiling, water determination and other quality-control methods appropriate for synthetic peptides.
Product: Tesamorelin
CAS Number: 218949-48-5
Acetate CAS: 901758-09-6
Formula: C221H366N72O67S
Molecular Weight: 5135.9 Da
Sequence Length: 44 amino acids
Category: Synthetic peptide / GHRF analogue
Appearance: White to off-white lyophilized powder
Tesamorelin is a peptide API and therefore requires analytical controls that differ from conventional small-molecule APIs. Identity may be established through LC-MS and chromatographic comparison, while purity and related peptide impurities are evaluated using validated chromatographic methods.
Tesamorelin binds to and stimulates human growth hormone-releasing factor receptors. This promotes endogenous growth hormone secretion and subsequently increases circulating IGF-1 and IGFBP-3 levels. FDA describes tesamorelin as a GHRF analogue whose pharmacological effects are mediated through stimulation of the growth hormone axis.
Tesamorelin is used as the active pharmaceutical ingredient in formulations intended for specific therapeutic applications involving excess abdominal fat associated with HIV-related lipodystrophy.
The FDA-approved EGRIFTA SV formulation is indicated for reduction of excess abdominal fat in HIV-infected adults with lipodystrophy. It is not indicated for general weight-loss management.
Tesamorelin API is therefore relevant to pharmaceutical development and manufacturing programs involving peptide-based injectable formulations.
Quality control of Tesamorelin API focuses on peptide-specific analytical characterization, including:
FDA chemistry documentation identifies HPLC assay and bioidentity testing as important components of Tesamorelin drug-product characterization.
Swapnroop Drugs and Pharmaceuticals is a WHO-GMP certified pharmaceutical company in India offering pharmaceutical raw materials and API products for domestic and international markets. The company states that it has operated since 2013, serves clients in 25+ countries and maintains a portfolio of 500+ products.
Tesamorelin API can be evaluated according to customer-specific quality requirements, analytical specifications and regulatory documentation needs. Product documentation can include Certificate of Analysis, Safety Data Sheet, analytical data and other applicable technical/regulatory documents.
Tesamorelin is a peptide and should be protected from conditions that may accelerate degradation, including excessive heat, moisture and prolonged exposure to light.
Reference peptide materials are commonly supplied as lyophilized solid and stored under frozen conditions. Cayman Chemical, for example, specifies storage at -20°C for its Tesamorelin acetate reference material. Final commercial storage conditions should follow the approved product specification and stability data for the specific API batch.
Typical technical documentation for Tesamorelin API may include:
Swapnroop Drugs and Pharmaceuticals operates a WHO-GMP certified pharmaceutical manufacturing and export network and states that it serves pharmaceutical customers across more than 25 countries. Its portfolio includes APIs and other pharmaceutical raw materials for domestic and international markets.
For Tesamorelin API requirements, pharmaceutical companies can request product specifications, analytical documentation, batch information and commercial details based on their intended formulation and regulatory market.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | NLT 98.0% |
| pH (1% Solution) | 4.0–7.0 |
| Individual Impurity | NMT 1.0% |
| Total Impurities | NMT 3.0% |
| Water Content | NMT 10.0% |