Description

5-Ethyl-5-Phenylhydantoin-n-Glucuronide is a high-purity conjugated metabolite, specifically the glucuronide derivative of 5-Ethyl-5-phenylhydantoin. This compound is of critical importance in pharmaceutical research and development, serving as a key reference standard for metabolism and pharmacokinetic studies. It is primarily required by analytical laboratories, contract research organizations (CROs), and pharmaceutical companies engaged in drug discovery, bioanalytical method development, and regulatory compliance testing. The product is supplied with full analytical documentation to ensure data integrity and traceability.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for quantitative bioanalysis in clinical and preclinical studies.
• Metabolite Identification & Profiling: Essential for identifying and characterizing Phase II metabolic pathways, specifically glucuronidation, of the parent drug.
• Bioanalytical Method Development & Validation: Used to develop, optimize, and validate LC-MS/MS, HPLC, or UPLC methods for accurate metabolite quantification in biological matrices.
• DMPK/ADME Studies: Critical component in Drug Metabolism and Pharmacokinetics (DMPK) and Absorption, Distribution, Metabolism, and Excretion (ADME) research to understand drug fate.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization of a major human metabolite.
• Quality Control in Manufacturing: Acts as a system suitability standard or for impurity profiling in the quality control of active pharmaceutical ingredients (APIs).

Basic Information

Product Name	5-Ethyl-5-Phenylhydantoin-n-Glucuronide
CAS No.	71562-63-5
Molecular Formula	C₁₉H₂₄N₂O₈
Molecular Weight	408.41 g/mol
Synonyms	5-Ethyl-5-phenylhydantoin glucuronide; Nirvanol glucuronide; 5-Ethyl-5-phenyl-2,4-imidazolidinedione 1-glucuronide; 1-((5-Ethyl-5-phenyl-2,4-dioxoimidazolidin-1-yl)oxy)-β-D-glucopyranuronic acid; Phenylethylhydantoin glucuronide; Mephenytoin metabolite glucuronide; Contact for additional synonyms.
EINECS	Contact for details

Quality Control

Our 5-Ethyl-5-Phenylhydantoin-n-Glucuronide is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assay and structural confirmation, to ensure it meets the high standards required for reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results for identity, purity, and impurities is provided with every shipment to guarantee traceability and reliability for your critical research applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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