Description

Rac Mephenytoin-D3 CAS NO 1185101-86-3 is a deuterium-labeled isotopologue of the anticonvulsant drug mephenytoin, serving as a critical internal standard in quantitative bioanalytical methods. This high-purity reference material is essential for ensuring accuracy and reproducibility in pharmacokinetic and metabolic studies, particularly for applications requiring mass spectrometry. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities focused on drug development and forensic toxicology.

Application

• Internal Standard for LC-MS/MS: Used as a deuterated internal standard for the precise quantification of mephenytoin and its metabolites in biological matrices (plasma, serum, urine).
• Drug Metabolism and Pharmacokinetics (DMPK): Facilitates studies on absorption, distribution, metabolism, and excretion (ADME) of mephenytoin.
• Forensic and Clinical Toxicology: Enables accurate measurement of mephenytoin levels in overdose cases or therapeutic drug monitoring.
• Cytochrome P450 Phenotyping: Supports research into CYP2C19 enzyme activity, for which mephenytoin is a probe substrate.
• Method Development and Validation: Critical for developing and validating robust, regulatory-compliant bioanalytical assays.
• Pharmaceutical Quality Control: Can be used in impurity profiling and stability-indicating methods for drug substance and product analysis.

Basic Information

Product Name	Rac Mephenytoin-D3
CAS No.	1185101-86-3
Molecular Formula	C12H11D3N2O2
Molecular Weight	221.27 g/mol
Synonyms	5-Ethyl-3-methyl-5-phenyl-2,4-imidazolidinedione-d3; (±)-Mephenytoin-d3; 3-Methyl-5,5-diphenylhydantoin-d3 (common misnomer); DL-Mephenytoin-d3; 5-Ethyl-5-phenyl-3-methylhydantoin-d3; Mesantoin-d3 (labeled); 5-Ethyl-3-methyl-5-phenylimidazolidine-2,4-dione-d3
EINECS	Contact for details

Quality Control

Our Rac Mephenytoin-D3 is manufactured under strict quality systems to ensure the high chemical and isotopic purity required for analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing parameters such as chemical purity (by HPLC), isotopic enrichment (by MS), and residual solvent content. We adhere to relevant industry standards for reference materials, and custom synthesis to meet specific pharmacopeial or client specifications is available upon request.

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 at 2-8°C. The product is light-sensitive and should be handled accordingly to maintain stability.

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 (D3)	≥ 98.0 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.