Description

Terlipressin Acetate is a synthetic vasopressin analogue, widely recognized for its potent and selective activity on V1 vascular receptors. This pharmaceutical active ingredient is critical for the management of acute variceal bleeding and related conditions, offering a more stable and longer-lasting therapeutic effect compared to vasopressin. It is an essential raw material for global pharmaceutical manufacturers engaged in the production of critical care and hepatology medications, requiring the highest standards of purity and consistency.

Application

• Pharmaceutical Active Ingredient (API): Primary use in the formulation of injectable drugs for the treatment of bleeding esophageal varices.
• Hepatorenal Syndrome Management: A key therapeutic agent in the treatment of type 1 hepatorenal syndrome, often used in hospital critical care settings.
• Vasoconstrictor Research: Used as a reference standard and research tool in pharmacological studies focusing on vasopressin receptor mechanisms and cardiovascular physiology.
• GMP Manufacturing: Sourced by contract development and manufacturing organizations (CDMOs) for the production of finished dosage forms under Good Manufacturing Practice (GMP) guidelines.
• Clinical Trial Material: Supplied as a critical component for clinical research into new therapeutic applications for vasoactive peptides.

Basic Information

Product Name	Terlipressin Acetate
CAS No.	68560-61-2
Molecular Formula	C52H74N16O15 • (C2H4O2)x
Molecular Weight	1227.4 g/mol (base)
Synonyms	Glypressin; Nα-Triglycyl-8-lysine-vasopressin; Terlipressin; TP; (Gly)3-LVP; Terlipressinum; Remestyp; Haemopressin; Terlipressin Acetate Salt
EINECS	Contact for details

Quality Control

Our Terlipressin Acetate is manufactured and tested to meet stringent pharmaceutical-grade specifications. Quality assurance protocols are designed to ensure identity, purity, strength, and composition, aligning with ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing results for assay, related substances, residual solvents, and microbiological attributes. We support audits and can supply documentation for regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled room temperature of 15-25°C or as specified on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to reference spectrum
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 2.0%
Single Maximum Unknown Impurity	≤ 0.5%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Bacterial Endotoxins	< 10 EU/mg
Microbial Enumeration	Complies with Ph. Eur. 2.6.12/2.6.13

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.