Description

Oxcarbazepine n--D-Glucuronide is a crucial glucuronide metabolite of the antiepileptic drug oxcarbazepine. This compound is of significant importance in pharmaceutical research and development, particularly for metabolism and pharmacokinetic studies. It serves as a primary analytical reference standard for bioanalytical method development and validation. Researchers and quality control laboratories in the pharmaceutical and biotechnology industries require this high-purity standard to ensure accurate drug monitoring and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for quantifying oxcarbazepine and its metabolites in biological matrices.
• Drug Metabolism and Pharmacokinetics (DMPK): Essential for studying the metabolic pathways, bioavailability, and excretion profile of oxcarbazepine.
• Bioanalytical Method Development: Used to develop and validate sensitive HPLC-MS/MS or LC-UV methods for therapeutic drug monitoring (TDM).
• Clinical Research: Supports studies investigating the correlation between metabolite levels, drug efficacy, and side effects in patients.
• Impurity Profiling: Acts as a known impurity standard for the quality control of oxcarbazepine active pharmaceutical ingredient (API) and finished dosage forms.
• Regulatory Submissions: Provides essential data for Investigational New Drug (IND) and New Drug Application (NDA) filings to health authorities like the FDA and EMA.

Basic Information

Product Name	Oxcarbazepine n--D-Glucuronide
CAS No.	1260595-39-8
Molecular Formula	C22H24N2O10
Molecular Weight	476.43 g/mol
Synonyms	Oxcarbazepine Glucuronide; Oxcarbazepine N-Glucuronide; 10,11-Dihydro-10-hydroxy-5H-dibenz[b,f]azepine-5-carboxamide Glucuronide; (10S)-10-Hydroxy-10,11-dihydro-5H-dibenzo[b,f]azepine-5-carboxamide β-D-Glucopyranosiduronic Acid; MHD Glucuronide; Monohydroxy Derivative Glucuronide; Licarbazepine Glucuronide; Contact for details on additional aliases.
EINECS	Contact for details

Quality Control

Every batch of Oxcarbazepine n--D-Glucuronide is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards for reference materials. Comprehensive characterization includes identity confirmation by spectroscopic methods (NMR, MS) and purity determination by HPLC. Certificates of Analysis (COA) are available upon request, providing batch-specific data on purity, impurities, and analytical results.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dedicated freezer. This product is hygroscopic (moisture-sensitive). Allow the sealed vial to equilibrate to room temperature before opening to minimize moisture condensation. For long-term storage, consider under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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