Description

Fenirofibrate o-B-D-Glucuronide is a major, pharmacologically active metabolite of the lipid-regulating agent fenofibrate. This compound is of critical importance in pharmaceutical research and development, particularly for studying drug metabolism, pharmacokinetics, and bioanalytical method validation. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and academic institutions engaged in metabolic profiling and the development of new therapeutic agents.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of fenofibrate and its metabolites in biological matrices.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Essential for in vitro and in vivo studies to understand the metabolic pathways, clearance mechanisms, and exposure levels of fenofibrate.
• Bioanalytical Method Development: Serves as a critical standard for developing and validating HPLC, LC-MS, and LC-MS/MS methods in compliance with FDA and ICH guidelines.
• Clinical Research: Used in clinical trials to monitor patient metabolite levels, assess drug safety, and establish pharmacokinetic/pharmacodynamic (PK/PD) relationships.
• Impurity Profiling: Employed in the identification and quantification of process-related impurities and degradation products in fenofibrate drug substance and finished dosage forms.
• Toxicology Studies: Applied in safety assessment programs to investigate the potential toxicological profile of fenofibrate metabolites.

Basic Information

Product Name	Fenirofibrate o-B-D-Glucuronide
CAS No.	168844-26-6
Molecular Formula	C28H35ClO11
Molecular Weight	583.03 g/mol
Synonyms	Fenofibrate Glucuronide; Fenofibrate Acyl Glucuronide; 1-O-[2-[4-(4-Chlorobenzoyl)phenoxy]-2-methylpropionyl]-β-D-glucopyranuronic Acid; Fenofibric Acid Glucuronide; Fenofibrate Metabolite Glucuronide; 2-{4-[(4-Chlorophenyl)carbonyl]phenoxy}-2-methylpropanoic Acid β-D-Glucopyranosiduronic Acid; CP 78,305-22 Glucuronide
EINECS	Contact for details

Quality Control

Our Fenirofibrate o-B-D-Glucuronide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, LC-MS for identity confirmation, and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical research. Certificates of Analysis (COA) with detailed chromatographic data are provided for every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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