Description

Bezafibrate is a fibric acid derivative and a well-established active pharmaceutical ingredient (API) primarily used as a lipid-lowering agent. Its core value lies in its efficacy in regulating blood lipid profiles by reducing triglycerides and LDL cholesterol while increasing HDL cholesterol. This compound is essential for pharmaceutical manufacturers developing treatments for hyperlipidemia and related cardiovascular conditions. Bezafibrate CAS NO 63927-29-7 is a critical intermediate and final API for producing high-quality, compliant therapeutic formulations.

Application

• Primary Pharmaceutical Ingredient: Manufacture of finished dosage forms (tablets, capsules) for the treatment of hyperlipidemia and dyslipidemia.
• Cardiovascular Disease Management: Key component in combination therapies aimed at reducing the risk of atherosclerosis, coronary artery disease, and pancreatitis.
• Research & Development: Used as a reference standard and biochemical tool in pharmacological studies of peroxisome proliferator-activated receptor (PPAR) agonists.
• Generic Drug Production: Sourcing of high-purity API for cost-effective generic versions of branded fibrate medications.
• Veterinary Pharmaceuticals: Potential application in lipid disorder management for companion animals under veterinary guidance.

Basic Information

Product Name	Bezafibrate
CAS No.	63927-29-7
Molecular Formula	C19H20ClNO4
Molecular Weight	361.82 g/mol
Synonyms	2-[4-[2-[(4-Chlorobenzoyl)amino]ethyl]phenoxy]-2-methylpropanoic Acid; BM 15075; Bezalip; Cedur; Difaterol; Bezafibratum; Bezafibrato; Bezafibrat
EINECS	Contact for details

Quality Control

Our Bezafibrate is produced and tested under strict quality management systems to ensure it meets the highest standards for pharmaceutical use. Quality assurance includes comprehensive analytical testing against relevant pharmacopoeial monographs (such as USP, EP, or BP) for identity, purity, and potency. A detailed Certificate of Analysis (COA), documenting results for assay, related substances, residual solvents, and microbiological quality, is provided with each batch 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). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed after opening to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White or almost white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 1.0% Any individual impurity ≤ 0.5%
Loss on Drying	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Microbiological Control	Total aerobic microbial count < 10³ CFU/g Total combined yeasts/molds < 10² CFU/g Absence of specified pathogens (E. coli, Salmonella)

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