Description

Carbamazepine 10,11-Epoxide-D2 (Major) is a deuterated analog of the primary active metabolite of the anticonvulsant drug carbamazepine. This compound is a critical reference standard and analytical tool for pharmacokinetic and metabolic studies, enabling precise quantification and differentiation from its non-deuterated counterpart. It is essential for researchers and quality control laboratories in the pharmaceutical industry, particularly those involved in drug development, bioanalytical method validation, and therapeutic drug monitoring.

Application

• Pharmaceutical Reference Standard: Serves as a certified internal standard for the accurate quantification of carbamazepine and its metabolites in biological matrices using LC-MS/MS and GC-MS.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Used in in vitro and in vivo studies to trace metabolic pathways, assess enzyme activity (e.g., CYP3A4), and determine pharmacokinetic parameters.
• Bioanalytical Method Development: Critical for developing and validating highly specific and sensitive assays for therapeutic drug monitoring (TDM) in patient plasma or serum.
• Impurity Profiling and Characterization: Acts as a marker for identifying and quantifying related substances in carbamazepine active pharmaceutical ingredient (API) and finished dosage forms.
• Clinical Research: Supports studies investigating the correlation between metabolite levels, drug efficacy, and adverse effects in patients undergoing carbamazepine therapy.

Basic Information

Product Name	Carbamazepine 10,11-Epoxide-D2 (Major)
CAS No.	1185025-41-5
Molecular Formula	C15H10D2N2O2
Molecular Weight	254.28 g/mol
Synonyms	10,11-Dihydro-10,11-epoxy-5H-dibenz[b,f]azepine-5-carboxamide-10,11-d2 (Major Isomer); CBZ-E-D2; Carbamazepine-10,11-epoxide-d2; 5H-Dibenz[b,f]azepine-5-carboxamide, 10,11-dihydro-10,11-epoxy-, 10,11-d2-; Deuterated Carbamazepine Epoxide; Carbamazepine-d2 Epoxide
EINECS	Contact for details

Quality Control

Our Carbamazepine 10,11-Epoxide-D2 (Major) is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including NMR, HPLC, and MS, to confirm chemical identity, isotopic purity (deuterium enrichment), and chemical purity. Certificates of Analysis (COA) detailing all specifications and test results are available upon request to support your regulatory and research documentation needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (NMR)	Conforms to structure
Identification (HPLC)	Conforms to reference
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D2)	≥ 98 atom % D
Water Content (KF)	≤ 0.5%
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.