Description

10,11-Dihydro-10-Hydroxycarbamazepine o--D-Glucuronide is a key metabolite and reference standard of the anticonvulsant drug carbamazepine. This compound is essential for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics, and bioanalytical method validation. It is primarily used by analytical laboratories, contract research organizations (CROs), and pharmaceutical companies engaged in bioequivalence studies and therapeutic drug monitoring.

Application

• Pharmaceutical Reference Standard: Serves as a certified primary standard for the quantitative and qualitative analysis of carbamazepine and its metabolites in biological matrices.
• Drug Metabolism & Pharmacokinetics (DMPK) Studies: Critical for investigating the metabolic pathways, clearance, and half-life of carbamazepine in preclinical and clinical research.
• Bioanalytical Method Development: Used to calibrate instruments and validate HPLC, LC-MS/MS, and other analytical methods for accurate detection and quantification.
• Therapeutic Drug Monitoring (TDM): Enables the precise measurement of active drug metabolite levels in patient plasma or serum to optimize dosing regimens.
• Impurity Profiling: Employed as a known impurity or degradation product standard to ensure the purity and safety of carbamazepine active pharmaceutical ingredients (APIs).
• Regulatory Compliance & Submission: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for drug metabolites.

Basic Information

Product Name	10,11-Dihydro-10-Hydroxycarbamazepine o--D-Glucuronide
CAS No.	144407-84-1
Molecular Formula	C22H24N2O9
Molecular Weight	460.44 g/mol
Synonyms	10,11-Dihydro-10-hydroxycarbamazepine O-β-D-glucuronide; Carbamazepine 10,11-epoxide O-β-D-glucuronide (reduced form); 10-Hydroxy-10,11-dihydrocarbamazepine O-glucuronide; CBZ-diol glucuronide; 10,11-Dihydro-10-hydroxy-CBZ glucuronide; Oxcarbazepine metabolite glucuronide (related); 5H-Dibenz[b,f]azepine-10,11-diol, 5-carbamoyl-10-(β-D-glucopyranuronosyl)-, (10S)-
EINECS	Contact for details

Quality Control

Every batch of 10,11-Dihydro-10-Hydroxycarbamazepine o--D-Glucuronide is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and stability testing to ensure compliance with the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity (by HPLC), identification (IR, NMR), and impurity profiles is provided with each shipment and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Specific Optical Rotation	Contact for details

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