Description

Eluxadoline Dihydrochloride is a high-purity, small-molecule active pharmaceutical ingredient (API) primarily used in the treatment of gastrointestinal disorders. Its core value lies in its targeted mechanism of action as a mixed μ-opioid receptor agonist and δ-opioid receptor antagonist, offering a specialized therapeutic option. This compound is essential for pharmaceutical manufacturers and research institutions engaged in developing and producing advanced medications for irritable bowel syndrome with diarrhea (IBS-D) and related conditions.

Application

• Primary Active Pharmaceutical Ingredient (API) in prescription medications for Irritable Bowel Syndrome with Diarrhea (IBS-D).
• Key intermediate in advanced pharmaceutical synthesis and process development.
• Reference standard for quality control and analytical method development in pharmaceutical laboratories.
• Biochemical research for studying opioid receptor pathways and gastrointestinal pharmacology.
• Preclinical and clinical research material for new drug development programs.

Basic Information

Product Name	Eluxadoline Dihydrochloride
CAS No.	864825-13-8
Molecular Formula	C32H35N5O5·2HCl
Molecular Weight	642.57 g/mol
Synonyms	5-[[(2S)-2-Amino-3-(4-carbamoyl-2,6-dimethylphenyl)propanoyl]amino]-3-(4-carboxy-2,6-dimethylphenyl)-4,6-dihydroxy-2-(4-hydroxyphenyl)cyclohexa-2,4-dien-1-one dihydrochloride; Eluxadoline HCl; Viberzi (Brand Name); JNJ-27018966; UR-1591
EINECS	Contact for details

Quality Control

Our Eluxadoline Dihydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for pharmaceutical use, including identity, purity, and impurity profile. A Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and other critical parameters is provided with every shipment to guarantee traceability and compliance.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Heavy Metals	≤ 20 ppm

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