Description

4-Hydroxy Mephenytoin-D3 is a stable isotope-labeled analog of the primary metabolite of the anticonvulsant drug mephenytoin. This compound is an essential reference standard and internal standard for quantitative bioanalytical studies, ensuring accurate and reliable pharmacokinetic and metabolic profiling. It is primarily used by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in drug metabolism and disposition (DMPK) studies, clinical research, and forensic toxicology.

Application

• Internal Standard for LC-MS/MS: Serves as a critical deuterated internal standard for the precise quantification of 4-hydroxy mephenytoin and related metabolites in complex biological matrices like plasma, serum, and urine.
• Drug Metabolism Studies (DMPK): Used in in vitro and in vivo studies to investigate the cytochrome P450 2C19 (CYP2C19) enzyme activity, which is crucial for understanding inter-individual variability in drug response.
• Clinical Research & Pharmacogenomics: Facilitates research into personalized medicine by enabling accurate measurement of metabolic phenotypes related to CYP2C19 polymorphism.
• Bioanalytical Method Development & Validation: A key component in developing, validating, and ensuring the robustness of analytical methods according to FDA, EMA, and ICH guidelines.
• Forensic & Toxicological Analysis: Employed in forensic laboratories for the definitive identification and quantification of mephenytoin and its metabolites in post-mortem or compliance testing scenarios.
• Manufacturing of Certified Reference Materials (CRMs): Used as a starting material for the production of certified reference standards with guaranteed purity and isotopic enrichment.

Basic Information

Product Name	4-Hydroxy Mephenytoin-D3
CAS No.	1173022-56-4
Molecular Formula	C12H11D3N2O2
Molecular Weight	221.27 g/mol
Synonyms	5-(4-Hydroxyphenyl)-5-methyl-3-(methyl-d3)-hydantoin; 4'-Hydroxymephenytoin-D3; 5-(4-Hydroxyphenyl)-5-methyl-3-(trideuteriomethyl)imidazolidine-2,4-dione; 4'-OH-Mephenytoin-D3; Nor-4'-Hydroxymephenytoin-D3 (potential); Deuteron-4-Hydroxy Mephenytoin; [Methyl-d3]-4-Hydroxy Mephenytoin; Mephenytoin 4-Hydroxy Metabolite-D3
EINECS	Contact for details

Quality Control

Every batch of 4-Hydroxy Mephenytoin-D3 is manufactured and analyzed under strict quality management systems. We guarantee high chemical and isotopic purity, confirmed by advanced spectroscopic and chromatographic techniques including NMR, HPLC, and LC-MS. Certificates of Analysis (COA) are provided, detailing batch-specific results for identity, purity (HPLC), isotopic enrichment (MS), and residual solvents. Our production adheres to cGMP principles suitable for use in regulated research and development.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Enrichment	≥ 98 atom % D
Chemical Purity (NMR)	Conforms
Residual Solvents (GC)	Meets ICH guidelines
Water Content (KF)	≤ 0.5%

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