Description

4-Hydroxy Mephenytoin is a key hydroxylated metabolite of the anticonvulsant drug mephenytoin. This compound is of significant value in pharmaceutical research and development, particularly for metabolic and pharmacokinetic studies. It serves as a critical reference standard and intermediate for analytical laboratories and manufacturers in the life sciences sector.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the quantification and qualification of mephenytoin and its metabolites in biological matrices.
• Drug Metabolism & Pharmacokinetics (DMPK): Essential for in vitro and in vivo studies to understand the metabolic pathways, clearance, and bioavailability of mephenytoin.
• Analytical Method Development: Used to develop and validate sensitive HPLC, LC-MS, and GC-MS methods for therapeutic drug monitoring and bioanalytical assays.
• Enzyme Activity Studies: A probe substrate for investigating the activity and polymorphism of cytochrome P450 enzymes, specifically CYP2C19.
• Impurity Profiling: Serves as a known impurity or degradation product standard in the quality control of mephenytoin active pharmaceutical ingredient (API).
• Clinical Research: Utilized in studies correlating metabolic ratios with patient genotype and phenotype for personalized medicine approaches.

Basic Information

Product Name	4-Hydroxy Mephenytoin
CAS No.	61837-65-8
Molecular Formula	C12H14N2O2
Molecular Weight	218.25 g/mol
Synonyms	4'-Hydroxymephenytoin; 5-Ethyl-3-methyl-5-(4-hydroxyphenyl)hydantoin; Nirvanol Metabolite; Mephenytoin Hydroxy Metabolite; 5-(4-Hydroxyphenyl)-5-ethyl-3-methylimidazolidine-2,4-dione; CYP2C19 Substrate Metabolite; 4-OH-Mephenytoin
EINECS	Contact for details

Quality Control

Our 4-Hydroxy Mephenytoin is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including identity confirmation by spectroscopic methods (IR, NMR) and purity assessment by HPLC to ensure it meets the high standards required for research and development. A comprehensive Certificate of Analysis (COA) detailing purity, impurities, and analytical results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to ensure stability.

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%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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