Description

10,11-Dihydro-10-Hydroxy Carbamazepine-D4 (Major) is a high-purity, deuterium-labeled analog of a key carbamazepine metabolite. This compound is essential for use as an internal standard in quantitative bioanalytical methods, ensuring the highest accuracy and reliability in pharmacokinetic and metabolic studies. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities focused on developing and validating assays for the antiepileptic drug carbamazepine and its derivatives.

Application

• Internal Standard for LC-MS/MS: Critical for the precise quantification of 10,11-dihydro-10-hydroxy carbamazepine (the active metabolite) in biological matrices such as plasma, serum, and urine.
• Pharmacokinetic (PK) Studies: Enables accurate tracking of metabolite concentration over time to determine drug exposure and half-life.
• Therapeutic Drug Monitoring (TDM): Supports the development of robust clinical assays to optimize carbamazepine dosing for individual patients.
• Drug Metabolism and Disposition Research: Used in in vitro and in vivo studies to elucidate the metabolic pathways of carbamazepine.
• Method Development & Validation: Serves as a certified reference material for establishing and validating new analytical protocols in compliance with FDA, EMA, and ICH guidelines.
• Manufacturing Quality Control: Can be utilized in the quality control of pharmaceutical manufacturing processes for carbamazepine-based products.

Basic Information

Product Name	10,11-Dihydro-10-Hydroxy Carbamazepine-D4 (Major)
CAS No.	1020719-39-4
Molecular Formula	C₁₅H₁₀D₄N₂O₂
Molecular Weight	~ 258.31 g/mol
Synonyms	10,11-Dihydro-10-hydroxycarbamazepine-d4; 10-Hydroxy-10,11-dihydrocarbamazepine-d4; 10-OH-CBZ-d4; Oxcarbazepine Metabolite MHD-d4; 10,11-Dihydro-10-hydroxy-5H-dibenzo[b,f]azepine-5-carboxamide-d4; Deuterated 10-Hydroxy Carbamazepine; 10,11-Dihydro-10-hydroxy-5H-dibenzo[b,f]azepine-5-carboxamide (phenyl-d4)
EINECS	Contact for details

Quality Control

Every batch of 10,11-Dihydro-10-Hydroxy Carbamazepine-D4 (Major) is manufactured and analyzed under strict quality systems. We guarantee high chemical purity and isotopic enrichment, supported by comprehensive analytical data including NMR, HPLC, and MS. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting purity, isotopic purity (D-enrichment), and confirming the absence of significant unlabeled impurities. Our quality commitment aligns with the standards expected for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material 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 (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98 atom % D
Chemical Purity (NMR)	Conforms
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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