Swapnroop is a pharmaceutical API manufacturer in India offering Terlipressin API for pharmaceutical manufacturing applications. Terlipressin is a synthetic peptide analogue of vasopressin and acts primarily as a vasopressin receptor agonist.
Terlipressin is a 12-amino-acid peptide and a prodrug of lysine vasopressin. It has greater selectivity for the V1 receptor compared with vasopressin and produces vasoconstrictor activity.
The pharmaceutical substance is commonly used in the acetate form, and regulatory products include Terlipressin Acetate for intravenous administration. Therefore, Terlipressin and Terlipressin Acetate should be distinguished when defining the exact API specification.
Terlipressin is a synthetic analogue of the naturally occurring hormone vasopressin. It is a peptide containing 12 amino acids with a disulfide bond and an amidated C-terminal glycine. PubChem identifies Terlipressin as a polypeptide with the molecular formula C52H74N16O15S2 and molecular weight 1227.4 g/mol.
Terlipressin has vasopressin receptor agonist activity and is used in pharmaceutical products requiring controlled vasoconstrictor effects. FDA-approved labeling for TERLIVAZ describes terlipressin as a vasopressin receptor agonist and identifies its use in patients with hepatorenal syndrome with rapid reduction in kidney function.
Product Name: Terlipressin
Common Synonyms: Glypressin, Glycylpressin
CAS No.: 14636-12-5
Molecular Formula: C52H74N16O15S2
Molecular Weight: 1227.4 g/mol
Drug Class: Vasopressin Receptor Agonist
Therapeutic Category: Vasopressor / Peptide API
Molecular Type: Synthetic peptide
Peptide Length: 12 amino acids
Sequence: GGGCYFQNCPKG-NH2
The identity, CAS number, molecular formula, molecular weight and peptide sequence are supported by PubChem.
Terlipressin is commonly formulated as Terlipressin Acetate for pharmaceutical use. FDA labeling for TERLIVAZ describes the product as containing terlipressin acetate and states that each vial contains 0.85 mg terlipressin equivalent to 1 mg terlipressin acetate. The labeled material is supplied as a sterile, preservative-free, lyophilized white-to-off-white powder for intravenous administration.
Terlipressin Acetate is chemically distinct from the free Terlipressin peptide and should therefore have its own identity and specification controls.
Terlipressin API is used in pharmaceutical products for applications including:
FDA labeling specifically identifies TERLIVAZ for improvement of renal function in adults with hepatorenal syndrome with rapid reduction in kidney function.
Terlipressin acts as a synthetic vasopressin analogue and vasopressin receptor agonist. It has greater selectivity for V1 receptors than for V2 receptors.
Its pharmacological activity produces vasoconstriction and increases effective arterial blood volume and mean arterial pressure. In patients with hepatorenal syndrome, this mechanism can increase renal blood flow by reducing portal hypertension and altering systemic and splanchnic circulation.
As a peptide API, Terlipressin requires specialized manufacturing and analytical controls. Quality evaluation should address peptide identity, purity, molecular characteristics, related peptide impurities, aggregation, residual solvents and other applicable quality attributes.
Analytical characterization may include chromatographic, spectroscopic and mass-spectrometric techniques appropriate for peptide drug substances.
Typical quality controls for Terlipressin API may include:
The exact acceptance criteria should be based on the applicable pharmacopoeial monograph, approved specification, regulatory requirements and the exact Terlipressin form being manufactured.
The European Pharmacopoeia index includes a specific Terlipressin monograph, confirming that Terlipressin is covered within the pharmacopoeial framework.
Swapnroop focuses on pharmaceutical API manufacturing in India, including quality-focused production and analytical control of pharmaceutical active ingredients.
Terlipressin is a peptide API requiring controlled manufacturing conditions, appropriate raw-material controls, peptide characterization and impurity monitoring. Swapnroop supports pharmaceutical customers requiring Terlipressin API for approved pharmaceutical manufacturing applications.
Terlipressin API should be packaged using suitable pharmaceutical-grade packaging designed to protect the peptide from moisture, contamination, temperature excursions and other environmental factors.
For peptide drug substances, storage conditions should be based on validated stability data and the approved product specification. Where applicable, controlled-temperature storage and protection from moisture should be maintained throughout handling and transportation.
Documentation for Terlipressin API may include:
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.5% |
| Water Content | NMT 10.0% |
| Specific Rotation | −108 to −88 |