Description

Fenofibrate CAS NO 49562-28-9 is a high-purity pharmaceutical active ingredient belonging to the fibrate class of compounds. It is a critical intermediate and active pharmaceutical ingredient (API) used in the manufacture of lipid-regulating medications. This compound is essential for pharmaceutical manufacturers and R&D facilities developing treatments for hypercholesterolemia and hypertriglyceridemia, ensuring the efficacy and safety of the final drug product.

Application

• Active Pharmaceutical Ingredient (API): Primary use as the key therapeutic agent in finished dosage forms for lipid management.
• Pharmaceutical Formulation: Used in the development and production of tablets, capsules, and other oral solid dosage forms.
• Generic Drug Manufacturing: Serves as a core component for producing cost-effective generic versions of fenofibrate-based medications.
• Research & Development: Utilized in preclinical and clinical studies for investigating new therapeutic applications and drug delivery systems.
• Reference Standard: Acts as a high-purity standard for analytical testing, quality control, and method validation in laboratories.
• Chemical Synthesis: Functions as a key intermediate or starting material for the synthesis of novel derivatives and related compounds.

Basic Information

Product Name	Fenofibrate
CAS No.	49562-28-9
Molecular Formula	C20H21ClO4
Molecular Weight	360.83 g/mol
Synonyms	Fenofibrate; Procetofen; 2-[4-(4-Chlorobenzoyl)phenoxy]-2-methylpropanoic acid 1-methylethyl ester; Isopropyl 2-[p-(p-chlorobenzoyl)phenoxy]-2-methylpropionate; Lipanthyl; Tricor; Lipidil; Lipofen; Fenobrate; Propiscan
EINECS	256-425-6

Quality Control

Our Fenofibrate is manufactured under strict quality management systems to ensure it meets the rigorous standards required for pharmaceutical applications. Each batch is tested against comprehensive specifications, including identity, purity, and impurity profiles, with methods aligned to current pharmacopeial standards (e.g., USP, EP). A Certificate of Analysis (COA) documenting all test results 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, and well-ventilated area at controlled room temperature (15-25°C). Keep away from heat, open flames, and incompatible materials.

Specification

Item	Specification
Appearance	White or almost white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Loss on Drying	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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