Description

Fenofibric Acid, Hydroxymethyl CAS NO 54419-31-7 is a key pharmaceutical intermediate and a metabolite of the lipid-regulating agent fenofibrate. This compound is critical for the research, development, and quality control of active pharmaceutical ingredients (APIs) targeting dyslipidemia and related metabolic disorders. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in drug synthesis, metabolite studies, and regulatory compliance testing.

Application

• Pharmaceutical Intermediate: A crucial building block in the synthesis of fenofibrate and its related analogs.
• Reference Standard: Serves as a certified reference material (CRM) for analytical method development, validation, and quality control in API and finished drug product manufacturing.
• Metabolite Studies: Used in pharmacokinetic and pharmacodynamic research to study the metabolism, bioavailability, and biological activity of fenofibrate.
• Impurity Profiling: Employed as an impurity marker to monitor and control the quality and purity of fenofibrate batches during production.
• Research & Development: Essential for medicinal chemistry programs aimed at developing new fibrate-class therapeutics or prodrugs.
• Regulatory Submissions: Provides necessary data and standards for regulatory filings (e.g., with FDA, EMA) to demonstrate drug safety and efficacy.

Basic Information

Product Name	Fenofibric Acid, Hydroxymethyl
CAS No.	54419-31-7
Molecular Formula	C17H15ClO4
Molecular Weight	318.75 g/mol
Synonyms	2-[4-(4-Chlorobenzoyl)phenoxy]-2-methylpropanoic acid, Hydroxymethyl derivative; Fenofibric Acid Hydroxymethyl; Hydroxymethyl Fenofibric Acid; 1-Methylethyl 2-[4-[(4-chlorophenyl)carbonyl]phenoxy]-2-methylpropanoate metabolite; Fenofibrate Acid Hydroxymethyl; Isopropyl 2-[p-(p-chlorobenzoyl)phenoxy]-2-methylpropionate hydroxymethyl derivative
EINECS	Contact for details

Quality Control

Our Fenofibric Acid, Hydroxymethyl is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, IR and NMR for structural confirmation, and residual solvent analysis, to ensure it meets high-purity standards suitable for pharmaceutical R&D and reference standard applications. Certificates of Analysis (COA) with detailed chromatograms and spectral data are provided for full traceability and regulatory support.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

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%
Related Substances (HPLC)	Total impurities ≤2.0% Any single impurity ≤0.5%
Loss on Drying	≤0.5%
Residue on Ignition	≤0.1%

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