Description

5-Phenyl-5-(4-Hydroxyphenyl)Hydantoin Glucuronide is a high-purity conjugated metabolite, primarily of the anticonvulsant drug phenytoin. This compound is of critical importance in pharmaceutical research and development, serving as a key reference standard for analytical and bioanalytical studies. It is essential for scientists and quality control professionals in the pharmaceutical, contract research organization (CRO), and clinical diagnostics sectors who require precise materials for method development, validation, and metabolite profiling.

Application

• Pharmaceutical Reference Standard: Primary use as an analytical standard for the quantification of phenytoin metabolites in biological matrices.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Critical for investigating the metabolic pathways, bioavailability, and excretion profiles of phenytoin.
• Clinical Toxicology and Therapeutic Drug Monitoring (TDM): Used to calibrate assays for monitoring patient plasma levels to ensure therapeutic efficacy and avoid toxicity.
• Biomarker Research: Employed in studies aiming to correlate drug metabolite levels with clinical outcomes or adverse effects.
• Method Development and Validation: Essential for developing and validating high-performance liquid chromatography (HPLC), LC-MS/MS, and other analytical techniques.
• Impurity Profiling: Used to identify and quantify related substances and degradation products in active pharmaceutical ingredient (API) batches.

Basic Information

Product Name	5-Phenyl-5-(4-Hydroxyphenyl)Hydantoin Glucuronide
CAS No.	53819-79-7
Molecular Formula	C23H22N2O8
Molecular Weight	454.43 g/mol
Synonyms	5-(4-Hydroxyphenyl)-5-phenylhydantoin Glucuronide; Phenytoin Glucuronide; HPPH Glucuronide; 5-(p-Hydroxyphenyl)-5-phenylhydantoin Glucuronide; 5-(4'-Hydroxyphenyl)-5-phenylhydantoin β-D-Glucuronide; (5RS)-5-(4-Hydroxyphenyl)-5-phenyl-2,4-imidazolidinedione 1-β-D-Glucopyranuronate; Major Phenytoin Metabolite Glucuronide
EINECS	Contact for details

Quality Control

Our 5-Phenyl-5-(4-Hydroxyphenyl)Hydantoin Glucuronide is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for research and reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, assay, and impurity profiles is provided with every shipment.

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); ensure the container is sealed tightly after each use to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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