Description

Difelikefalin Acetate is a selective kappa opioid receptor (KOR) agonist, specifically developed as an active pharmaceutical ingredient (API). This compound is of significant commercial interest for its targeted mechanism of action in managing moderate-to-severe pruritus, particularly in chronic kidney disease patients undergoing hemodialysis. It is primarily required by pharmaceutical manufacturers and advanced research institutions engaged in the development of novel therapeutics for unmet medical needs in dermatology and nephrology.

Application

• Active Pharmaceutical Ingredient (API): Core component in the formulation of injectable therapeutics for chronic pruritus.
• Clinical Research & Development: Used in preclinical and clinical studies to investigate KOR agonist efficacy and safety profiles.
• Pharmaceutical Reference Standard: Serves as a high-purity standard for analytical method development, validation, and quality control testing.
• Drug Discovery Programs: A key compound for researching new indications for KOR agonists beyond pruritus.
• Contract Manufacturing: Supplied to CDMOs for the commercial-scale production of finished dosage forms.
• Academic Research: Utilized in university and institutional labs studying opioid receptor pharmacology and signaling pathways.

Basic Information

Product Name	Difelikefalin Acetate
CAS No.	1024829-44-4
Molecular Formula	C₃₂H₄₀N₆O₈ • xC₂H₄O₂
Molecular Weight	Contact for details
Synonyms	CR845; FE 202845; Difelikefalin acetate salt; (D-Phe)-(D-Ala)-Gly-(D-Trp)-Pro-Glu-NH₂ acetate; Korsuva (brand name related); Kappa opioid receptor agonist CR845; FE-202845
EINECS	Contact for details

Quality Control

Our Difelikefalin Acetate is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, residual solvent analysis, and identification by spectroscopic methods, to ensure it meets stringent specifications suitable for pharmaceutical development. A Certificate of Analysis (COA) detailing all test results is provided with every shipment to guarantee traceability and compliance with cGMP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Assay (HPLC)	≥98.0%
Single Impurity (HPLC)	≤1.0%
Total Impurities (HPLC)	≤2.0%
Water Content (KF)	≤5.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines

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