Description

Rac Mephenytoin-D5 is a deuterated analog of the anticonvulsant drug mephenytoin, specifically designed for use as an internal standard in quantitative bioanalytical methods. This stable isotope-labeled compound is essential for ensuring the accuracy and reliability of mass spectrometry-based analyses in pharmacokinetic and metabolic studies. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers engaged in drug development and forensic toxicology.

Application

• Internal Standard for LC-MS/MS: Critical for the precise quantification of mephenytoin and its metabolites in complex biological matrices like plasma, serum, and urine.
• Drug Metabolism and Pharmacokinetics (DMPK): Used in studies to understand the absorption, distribution, metabolism, and excretion (ADME) profile of mephenytoin.
• Forensic and Clinical Toxicology: Enables accurate measurement of mephenytoin levels in cases of overdose monitoring or therapeutic drug monitoring (TDM).
• Pharmacogenetic Research: Supports investigations into cytochrome P450 2C19 (CYP2C19) enzyme activity, for which mephenytoin is a probe substrate.
• Method Development and Validation: Serves as a key component in developing and validating robust, regulatory-compliant bioanalytical assays.
• Reference Material: Acts as a high-purity certified reference material for calibrating analytical instruments and ensuring data integrity.

Basic Information

Product Name	Rac Mephenytoin-D5
CAS No.	1185032-66-9
Molecular Formula	C12H9D5N2O2
Molecular Weight	221.27 g/mol
Synonyms	5-Ethyl-3-methyl-5-phenyl-2,4-imidazolidinedione-d5; (±)-Mephenytoin-d5; 5,5-Diphenyl-3-ethylhydantoin-d5; Mephenytoin (phenyl-d5); NSC 25223-d5; 3-Methyl-5,5-diphenylhydantoin-d5; 5-Ethyl-5-phenyl-3-methylhydantoin-d5
EINECS	Contact for details

Quality Control

Every batch of Rac Mephenytoin-D5 is manufactured and tested under strict quality management systems. We guarantee high chemical and isotopic purity, supported by comprehensive analytical data including NMR, HPLC, and mass spectrometry. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting purity, isotopic enrichment, and confirming the absence of significant impurities. Our quality commitment ensures the material meets the stringent requirements for use in GLP and GMP-regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-content)	≥ 98 atom % D
Chemical Purity (NMR)	Conforms
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.