Description

Entacapone 3-B-D-Glucuronide is a major, pharmacologically inactive metabolite of the catechol-O-methyltransferase (COMT) inhibitor Entacapone. This compound is of critical importance for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics, and bioanalytical method validation. It serves as a key reference standard for laboratories in the pharmaceutical and biotechnology sectors, enabling accurate quantification and characterization of Entacapone and its metabolic pathways in biological matrices.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for quality control and analytical testing of Entacapone drug substances and products.
• Metabolite Identification & Profiling: Essential for in vitro and in vivo metabolism studies to understand the biotransformation and clearance of the parent drug, Entacapone.
• Bioanalytical Method Development: Used as a critical standard for developing and validating sensitive HPLC, LC-MS, or LC-MS/MS assays in plasma, serum, or urine.
• Pharmacokinetic (PK) & Toxicokinetic (TK) Studies: Enables precise measurement of metabolite levels to assess exposure, half-life, and safety profiles in preclinical and clinical trials.
• Impurity Profiling: Acts as a specified impurity or degradation product standard for stability-indicating methods in pharmaceutical manufacturing.
• Regulatory Submissions: Supports Investigational New Drug (IND) and New Drug Application (NDA) filings by providing definitive characterization data for a major metabolite.

Basic Information

Product Name	Entacapone 3-B-D-Glucuronide
CAS No.	158069-75-1
Molecular Formula	C₂₄H₂₄N₂O₁₁
Molecular Weight	516.46 g/mol
Synonyms	(E)-2-Cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide 3-β-D-Glucuronide; Entacapone Glucuronide; Entacapone 3-O-β-D-Glucuronide; COMtan Metabolite; EGP 1; (2E)-2-Cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylprop-2-enamide 3-(β-D-Glucopyranosiduronic Acid)
EINECS	Contact for details

Quality Control

Our Entacapone 3-B-D-Glucuronide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. The material is suitable for use as a pharmaceutical reference standard in regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent absorption of water vapor.

Specification

Item	Specification
Appearance	Off-white to light yellow powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	< 20 ppm

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