Description

Gemfibrozil 1-o--Glucuronide is a major, pharmacologically active metabolite of the lipid-regulating drug gemfibrozil. This compound is crucial for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics, and bioequivalence. It serves as a critical reference standard and analytical standard for laboratories in the pharmaceutical, biotechnology, and contract research organization (CRO) sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified standard for quantitative and qualitative analysis in drug development and quality control.
• Metabolite Identification & Profiling: Essential for in vitro and in vivo studies to map the metabolic pathways of gemfibrozil.
• Bioanalytical Method Development: Used to develop and validate HPLC, LC-MS, and LC-MS/MS methods for quantifying gemfibrozil and its metabolites in biological matrices.
• Pharmacokinetic (PK) and Toxicokinetic (TK) Studies: Critical for understanding the absorption, distribution, metabolism, and excretion (ADME) profile of the parent drug.
• Impurity Standard: Employed as a known impurity for stability testing and method validation to ensure drug product purity and safety.
• Clinical Research: Supports studies on drug-drug interactions and individual metabolic variability in response to gemfibrozil therapy.

Basic Information

Product Name	Gemfibrozil 1-o--Glucuronide
CAS No.	91683-38-4
Molecular Formula	C23H28O9
Molecular Weight	448.47 g/mol
Synonyms	Gemfibrozil 1-O-β-Glucuronide; Gemfibrozil O-Glucuronide; 5-(2,5-Dimethylphenoxy)-2,2-dimethylpentanoic Acid 1-O-β-Glucuronide; 1-O-(5-(2,5-Dimethylphenoxy)-2,2-dimethylpentanoyl)-β-D-glucopyranuronic Acid; Gemfibrozil Glucuronide; Gemfibrozil Acyl Glucuronide
EINECS	Contact for details

Quality Control

Our Gemfibrozil 1-o--Glucuronide is produced under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical research. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting purity, batch number, and analytical results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. For long-term storage, consider storing at -20°C. The product is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH guidelines

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