Description

Gemfibrozil is a fibric acid derivative and a well-established active pharmaceutical ingredient (API) primarily used as a lipid-regulating agent. Its core value lies in its efficacy in managing hyperlipidemia by lowering elevated serum triglycerides and very-low-density lipoprotein (VLDL) cholesterol levels. This compound is essential for pharmaceutical manufacturers developing and producing prescription medications for cardiovascular health. Gemfibrozil CAS NO 5812-30-0 is a critical component in formulations aimed at reducing the risk of coronary heart disease.

Application

• Primary Pharmaceutical Ingredient: As the active component in finished dosage forms, primarily oral tablets and capsules, for the treatment of hypertriglyceridemia (Type IV hyperlipidemia) and mixed dyslipidemia (Type IIb).
• Generic Drug Manufacturing: Serves as the key API for the production of cost-effective generic versions of lipid-lowering medications, ensuring wider patient access.
• Clinical Research & Development: Used in preclinical and clinical studies for investigating new therapeutic applications, combination therapies, or novel drug delivery systems for metabolic disorders.
• Reference Standard: High-purity grades are utilized as analytical reference standards in quality control laboratories for method development, validation, and assay testing of pharmaceutical products.
• Bulk Pharmaceutical Intermediates: May be employed in the synthesis of more complex pharmaceutical compounds or derivatives in specialized research settings.

Basic Information

Product Name	Gemfibrozil
CAS No.	5812-30-0
Molecular Formula	C15H22O3
Molecular Weight	250.33 g/mol
Synonyms	5-(2,5-Dimethylphenoxy)-2,2-dimethylpentanoic Acid; CI-719; Lipozid; Lopid; Jezil; Gemlipid; Gemnpid; 2,2-Dimethyl-5-(2,5-xylyloxy)valeric Acid
EINECS	227-363-0

Quality Control

Our Gemfibrozil is manufactured and tested under a strict quality management system. We ensure compliance with major pharmacopoeial standards, including USP (United States Pharmacopeia) and EP (European Pharmacopoeia) monographs, where applicable. Each batch undergoes comprehensive analytical testing for identity, purity, potency, and specified impurities. A detailed Certificate of Analysis (COA), documenting all test results against release specifications, is provided with every shipment to guarantee traceability and product integrity.

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). This product is hygroscopic (moisture-sensitive); the container must be kept tightly sealed to prevent absorption of atmospheric moisture, which may affect stability and handling properties.

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)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Specific Optical Rotation	- Contact for details -

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