Description

(S)-4-Hydroxy Mephenytoin is a significant chiral metabolite of the anticonvulsant drug mephenytoin. This compound matters as a crucial reference standard and intermediate in pharmaceutical research and development, particularly for studying drug metabolism and stereoselective pharmacokinetics. It is primarily needed by pharmaceutical companies, contract research organizations (CROs), and academic institutions engaged in analytical method development, metabolic pathway elucidation, and the synthesis of novel therapeutic agents.

Application

• Pharmaceutical Reference Standard: Used as a high-purity certified standard for quantitative and qualitative analysis in HPLC, LC-MS, and GC-MS methods.
• Drug Metabolism Studies: Serves as a key metabolite for investigating the stereoselective metabolism, pharmacokinetics, and pharmacodynamics of mephenytoin and related compounds.
• Biochemical Research: Employed in enzymatic studies, particularly those involving cytochrome P450 isoforms like CYP2C19, to understand polymorphism and inter-individual variability in drug response.
• Chiral Intermediate: Acts as a building block in the asymmetric synthesis of more complex molecules for medicinal chemistry programs.
• Analytical Method Development: Utilized for developing and validating robust chromatographic assays for metabolite identification and quantification in biological matrices.
• Quality Control: Applied in the quality assurance and control laboratories of pharmaceutical manufacturers to ensure batch consistency and purity of active pharmaceutical ingredients (APIs).

Basic Information

Product Name	(S)-4-Hydroxy Mephenytoin
CAS No.	82695-93-0
Molecular Formula	C12H14N2O2
Molecular Weight	218.25 g/mol
Synonyms	(S)-4-Hydroxymephenytoin; (S)-5-Ethyl-3-methyl-5-phenyl-2,4-imidazolidinedione, 4-hydroxy-; 4-Hydroxy Mephenytoin (S-enantiomer); (S)-Nirvanol metabolite; (S)-Mephenytoin Hydroxy Metabolite; (S)-5-Ethyl-3-methyl-5-phenyl-4-hydroxyhydantoin; (S)-4'-Hydroxymephenytoin
EINECS	Contact for details

Quality Control

Our (S)-4-Hydroxy Mephenytoin is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chiral purity verification by HPLC, to ensure it meets the high standards required for pharmaceutical research. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profiles is provided with every shipment to guarantee traceability and batch-to-batch consistency.

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) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference standard
Assay (HPLC)	≥98.0%
Chiral Purity (HPLC)	≥99.0% (S-enantiomer)
Related Substances (HPLC)	Total impurities ≤2.0%
Loss on Drying	≤1.0%
Residue on Ignition	≤0.1%

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