Description

Gemfibrozil is a synthetic derivative of fibric acid, widely recognized for its role as a lipid-regulating agent. Its primary commercial value lies in its efficacy as an active pharmaceutical ingredient (API) for the production of cholesterol-lowering medications. This compound is essential for pharmaceutical manufacturers and research institutions developing treatments for hyperlipidemia and related cardiovascular conditions. Gemfibrozil CAS NO 25812-30-0 is supplied to meet the stringent quality demands of the global pharmaceutical supply chain.

Application

• Active Pharmaceutical Ingredient (API): Primary use in the formulation of oral medications for reducing elevated serum triglycerides and cholesterol (VLDL).
• Generic Drug Manufacturing: Serves as the key therapeutic component in generic versions of lipid-modifying drugs.
• Pharmaceutical Research & Development: Used in preclinical and clinical studies for investigating new therapeutic applications and drug combinations.
• Reference Standard: Employed as an analytical standard in quality control laboratories for HPLC, LC-MS, or pharmacopeial testing.
• Biochemical Research: Utilized in metabolic studies to investigate PPAR-alpha (Peroxisome Proliferator-Activated Receptor Alpha) agonist activity.

Basic Information

Item	Detail
Product Name	Gemfibrozil
CAS No.	25812-30-0
Molecular Formula	C15H22O3
Molecular Weight	250.33 g/mol
Synonyms	5-(2,5-Dimethylphenoxy)-2,2-dimethylpentanoic Acid; CI-719; Lipozid; Lopid; GEM; 2,2-Dimethyl-5-(2,5-xylyloxy)valeric Acid; Jezil
EINECS	247-279-4

Quality Control

Our Gemfibrozil is manufactured and tested under a strict quality management system. Each batch is analyzed to ensure compliance with major pharmacopeial standards such as USP and EP. A comprehensive Certificate of Analysis (COA) is provided, detailing results for identity, purity, assay, and specified impurities. We ensure traceability and batch-to-batch consistency to support our clients' regulatory filings and production needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated place 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 to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	NMT 0.5%
Residue on Ignition	NMT 0.1%
Related Substances (HPLC)	Total impurities: NMT 1.0% Any individual impurity: NMT 0.5%
Heavy Metals	NMT 20 ppm

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