Description

Tolcapone 3-B-D-Glucuronide is a major, pharmacologically inactive metabolite of the drug tolcapone, formed via glucuronidation. This reference standard is critical for analytical and bioanalytical research, enabling accurate quantification and metabolic profiling. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and quality control departments for method development, validation, and regulatory compliance in drug metabolism and pharmacokinetic (DMPK) studies.

Application

• Pharmacokinetic and Metabolism Studies: Used as a certified reference standard to quantify the primary metabolite of tolcapone in biological matrices (plasma, urine).
• Bioanalytical Method Development & Validation (FDA/EMA): Essential for developing and validating robust HPLC-MS/MS or LC-UV methods for clinical trial sample analysis.
• Impurity Profiling and Drug Substance Characterization: Serves as a well-defined impurity standard for the quality control of tolcapone active pharmaceutical ingredient (API).
• DMPK Research: Facilitates investigations into the absorption, distribution, metabolism, and excretion (ADME) pathways of tolcapone.
• Regulatory Submissions: Provides essential data for Investigational New Drug (IND) and New Drug Application (NDA) filings to demonstrate comprehensive metabolic understanding.
• Clinical Research: Supports studies monitoring metabolite levels to understand individual metabolic variations and potential drug interactions.

Basic Information

Product Name	Tolcapone 3-B-D-Glucuronide
CAS No.	204853-33-8
Molecular Formula	C17H19NO10
Molecular Weight	397.33 g/mol
Synonyms	3-O-β-D-Glucopyranuronosyl tolcapone; Tolcapone 3-O-β-D-Glucuronide; Tolcapone Glucuronide; (3,4-Dihydroxy-5-nitrobenzophenone-4-yl) β-D-Glucopyranosiduronic Acid; ENTACAPONE Impurity G (Glucuronide); COMT Inhibitor Metabolite
EINECS	Contact for details

Quality Control

Every batch of Tolcapone 3-B-D-Glucuronide is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data to ensure identity, purity, and consistency, meeting the stringent requirements for pharmaceutical reference standards. A detailed Certificate of Analysis (COA) containing results for assay, related substances, residual solvents, and spectroscopic confirmation is supplied with each shipment.

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 compound is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.0%
Related Substances (HPLC)	Total impurities ≤2.0% Any single unknown impurity ≤0.5%
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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