Description

R-Licarbazepine Glucuronide Sodium Salt is a high-purity reference standard and pharmaceutical intermediate, specifically the sodium salt of the glucuronide conjugate of the active metabolite of oxcarbazepine. This compound is of critical importance for analytical method development, pharmacokinetic studies, and quality control in the manufacturing of advanced pharmaceutical products. It is primarily utilized by research institutions, analytical laboratories, and pharmaceutical companies engaged in the development and production of central nervous system (CNS) therapeutics.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the quantitative and qualitative analysis of licarbazepine metabolites in drug substances and finished products.
• Metabolite Research: Essential for in vitro and in vivo studies investigating the metabolism, pharmacokinetics, and pharmacodynamics of oxcarbazepine and related anticonvulsant drugs.
• Bioanalytical Method Development: Used to develop and validate sensitive HPLC, LC-MS, and LC-MS/MS methods for therapeutic drug monitoring and clinical studies.
• Impurity Profiling: Employed to identify and quantify glucuronide conjugate impurities in active pharmaceutical ingredient (API) batches to ensure compliance with ICH guidelines.
• Preclinical & Clinical Trials: A key material for dosing solutions and calibration standards in non-clinical and clinical trial phases for new CNS drug candidates.

Basic Information

Product Name	R-Licarbazepine Glucuronide Sodium Salt
CAS No.	104746-01-2
Molecular Formula	C22H23N2NaO9
Molecular Weight	482.42 g/mol
Synonyms	(10R)-10,11-Dihydro-10-hydroxy-5H-dibenzo[b,f]azepine-5-carboxamide 10-Glucuronide Sodium Salt; (R)-Licarbazepine Glucuronide Sodium; Sodium (5R)-5-[(10R)-10-hydroxy-5-carbamoyl-10,11-dihydro-5H-dibenzo[b,f]azepin-10-yl]-β-D-glucopyranosiduronate; Oxcarbazepine Metabolite Glucuronide Sodium Salt; MHD Glucuronide Sodium Salt
EINECS	Contact for details

Quality Control

Every batch of R-Licarbazepine Glucuronide Sodium Salt is manufactured under strict quality management systems and undergoes comprehensive analytical testing. Our products are characterized using advanced techniques including NMR, HPLC, and mass spectrometry to ensure identity, purity, and consistency. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications suitable for research and pharmaceutical development.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Assay (HPLC)	≥98.0%
Purity (HPLC, Area %)	≥99.0%
Water Content (KF)	≤2.0%
Residue on Ignition	≤0.5%
Heavy Metals	≤20 ppm

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