Description

Choline Fenofibrate is a choline salt of fenofibric acid, representing a significant advancement in the formulation of lipid-regulating agents. This compound is valued for its enhanced solubility and bioavailability profile compared to the parent acid, making it a critical active pharmaceutical ingredient (API) for modern therapeutic development. It is primarily utilized by pharmaceutical manufacturers and research institutions engaged in the formulation of next-generation treatments for dyslipidemia and related cardiovascular conditions. Our supply of Choline Fenofibrate CAS NO 856676-23-8 is characterized by stringent quality control to meet the exacting standards of global pharmaceutical production.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription medications for treating hypertriglyceridemia and mixed dyslipidemia.
• Fixed-Dose Combination Drugs: Formulation into combination therapies, often paired with statins, for comprehensive cardiovascular risk management.
• Drug Delivery R&D: Research into novel delivery systems (e.g., sustained-release, nano-formulations) to optimize pharmacokinetics and patient compliance.
• Reference Standard: Serves as a high-purity analytical standard for quality control and regulatory testing in pharmaceutical laboratories.
• Metabolic Disorder Research: Used in preclinical and clinical studies investigating lipid metabolism, PPAR-alpha activation, and related metabolic pathways.
• Generic Drug Manufacturing: Sourcing for the production of bioequivalent generic versions of branded fenofibrate medications.

Basic Information

Item	Details
Product Name	Choline Fenofibrate
CAS No.	856676-23-8
Molecular Formula	C₂₂H₃₀ClNO₅
Molecular Weight	423.93 g/mol
Synonyms	Fenofibrate Choline Salt; Choline Fenofibrate; 2-Hydroxy-N,N,N-trimethylethanaminium salt with 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoic acid (1:1); ABT-335 (Choline Salt); Trilipix (API); Choline Salt of Fenofibric Acid; [2-Hydroxyethyl]trimethylammonium Fenofibrate
EINECS	Contact for details

Quality Control

Our Choline Fenofibrate is manufactured under a quality management system designed for pharmaceutical intermediates and APIs. Each batch is subjected to rigorous analytical testing, including identification, assay, and impurity profiling via HPLC, to ensure it meets high-purity specifications. We support compliance with ICH guidelines for stability and impurities. A comprehensive Certificate of Analysis (COA), detailing all test results against release specifications, is provided with every shipment and is available for review upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Residual Solvents (GC)	Complies with 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.