Description

3-Hydroxymephenytoin is a key metabolite of the anticonvulsant drug mephenytoin, serving as a critical reference standard and intermediate in pharmaceutical research and development. Its primary value lies in enabling precise analytical studies of drug metabolism, pharmacokinetics, and bioequivalence. This compound is essential for laboratories in the pharmaceutical, contract research organization (CRO), and academic sectors focused on neuropharmacology and analytical method development.

Application

• Pharmaceutical Reference Standard: Used as a certified standard for the quantitative and qualitative analysis of mephenytoin and its metabolites in biological matrices via HPLC, LC-MS, or GC-MS.
• Drug Metabolism Studies: A vital tool for investigating the cytochrome P450-mediated metabolic pathways, specifically CYP2C19 activity, in preclinical and clinical research.
• Impurity Profiling: Employed in the identification and quantification of process-related impurities or degradation products in mephenytoin active pharmaceutical ingredient (API) manufacturing.
• Biomarker Research: Utilized in studies exploring phenotypic differences in drug metabolism rates among populations for personalized medicine approaches.
• Toxicological Analysis: Serves as an analytical marker in forensic and clinical toxicology to assess mephenytoin exposure or overdose.
• Enzyme Kinetics: Applied in in vitro assays to study enzyme inhibition or induction, aiding in drug-drug interaction studies.

Basic Information

Product Name	3-Hydroxymephenytoin
CAS No.	74634-57-4
Molecular Formula	C12H14N2O3
Molecular Weight	234.25 g/mol
Synonyms	3-Hydroxy-5-ethyl-5-phenylhydantoin; 5-Ethyl-3-hydroxy-5-phenylhydantoin; 5-Ethyl-5-phenyl-3-hydroxy-2,4-imidazolidinedione; Mephenytoin Hydroxy Metabolite; Nirvanol Metabolite; 3-OH-Mephenytoin; NSC 113935
EINECS	Contact for details

Quality Control

Our 3-Hydroxymephenytoin is produced under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification (IR, NMR), purity assay (HPLC), and control of specified impurities, to ensure it meets the high standards required for research and development. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and regulatory compliance.

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 maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5% Total impurities ≤ 1.5%
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.