Description

Oxcarbazepine-D4 is a deuterium-labeled analog of the active pharmaceutical ingredient oxcarbazepine, specifically designed for use as an internal standard in analytical chemistry. This high-purity stable isotope-labeled compound is essential for ensuring the accuracy and reliability of quantitative analyses, particularly in pharmacokinetic and bioequivalence studies. It is a critical material for pharmaceutical R&D laboratories, contract research organizations (CROs), and manufacturers engaged in the development and quality control of antiepileptic drugs.

Application

• Internal Standard for LC-MS/MS: Primary application as a quantitative reference standard in liquid chromatography-tandem mass spectrometry for the analysis of oxcarbazepine and its metabolites in biological matrices.
• Pharmacokinetic Research: Enables precise measurement of drug absorption, distribution, metabolism, and excretion (ADME) profiles in clinical and preclinical studies.
• Bioanalytical Method Development & Validation: Used to develop, optimize, and validate robust analytical methods compliant with FDA, EMA, and ICH guidelines.
• Drug Metabolism Studies: Facilitates the identification and quantification of drug metabolites, aiding in metabolic pathway elucidation.
• Quality Control & Assurance: Serves as a critical component in the in-house quality control testing of pharmaceutical products containing oxcarbazepine.
• Forensic & Clinical Toxicology: Supports accurate drug monitoring and toxicological screening in forensic and clinical laboratory settings.

Basic Information

Item	Detail
Product Name	Oxcarbazepine-D4
CAS No.	1134188-71-8
Molecular Formula	C15H8D4N2O2
Molecular Weight	256.28 g/mol (approx.)
Synonyms	10,11-Dihydro-10-oxo-5H-dibenz[b,f]azepine-5-carboxamide-10,11,11-d4; Oxcarbazepine-d4; 10-Oxo-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide-d4; Deuterated Oxcarbazepine; [2H4]-Oxcarbazepine; GP 47779-d4; Trileptal-d4 (labeled analog)
EINECS	Contact for details

Quality Control

Our Oxcarbazepine-D4 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including NMR and Mass Spectrometry for isotopic enrichment verification and HPLC for chemical and isomeric purity. We provide full traceability and Certificates of Analysis (COA) detailing batch-specific results for identity, assay, isotopic purity, and related substances, supporting compliance with cGMP and ICH Q7 guidelines for active pharmaceutical ingredients.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The product is hygroscopic (moisture-sensitive); keep the container in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0% (chemical purity)
Isotopic Purity	≥ 98.0 atom % D
Isomeric Purity (HPLC)	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.