Description

Entacapone 4-β-D-Glucuronide is a major, pharmacologically inactive metabolite of the catechol-O-methyltransferase (COMT) inhibitor entacapone. This compound is of critical importance in pharmaceutical research and development, serving as a primary reference standard for bioanalytical studies. It is essential for scientists and quality control laboratories in the pharmaceutical industry who require precise quantification and metabolic profiling of entacapone in biological matrices during pharmacokinetic and bioequivalence studies.

Application

• Pharmaceutical Reference Standard: Primary application as a certified reference material (CRM) for the quantitative analysis of entacapone and its metabolites in biological samples (plasma, urine).
• Metabolite Identification & Profiling: Used in drug metabolism and pharmacokinetics (DMPK) studies to identify and characterize the glucuronidation pathway of entacapone.
• Bioanalytical Method Development & Validation: Critical for developing and validating sensitive and specific LC-MS/MS or HPLC-UV methods for therapeutic drug monitoring (TDM) and clinical trials.
• Impurity Standard: Can be utilized as a specified impurity standard in the quality control of entacapone active pharmaceutical ingredient (API) to ensure purity and safety.
• Toxicology Studies: Employed in preclinical and clinical studies to understand the excretion profile and safety of entacapone's major metabolite.

Basic Information

Product Name	Entacapone 4-β-D-Glucuronide
CAS No.	314058-42-9
Molecular Formula	C₂₄H₂₄N₂O₁₁
Molecular Weight	516.46 g/mol
Synonyms	(E)-2-Cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide 4-β-D-Glucuronide; Entacapone Glucuronide; Entacapone 4-O-β-D-Glucuronide; COMtan Metabolite (Glucuronide); (2E)-2-Cyano-3-(4,5-dihydroxy-2-nitrophenyl)-N,N-diethylprop-2-enamide 4-(β-D-glucopyranuronosyl) ether
EINECS	Contact for details

Quality Control

Our Entacapone 4-β-D-Glucuronide is manufactured and tested under strict quality systems suitable for use as a reference standard. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile, typically determined by advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) methods. We ensure compliance with relevant guidelines for reference standards. Certificates of Analysis (COA) are available upon request.

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. This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	Off-white to light yellow powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Specific Optical Rotation	Contact for details

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