Description

Deacetamidine Cyano Dabigatran-D3 Ethyl Ester is a high-purity, deuterium-labeled chemical reference standard of significant importance in pharmaceutical research and development. Its core value lies in enabling precise analytical quantification and metabolic studies of the anticoagulant drug dabigatran etexilate and its intermediates. This compound is essential for researchers and quality control laboratories in the pharmaceutical and biotechnology sectors who require stable isotope-labeled internal standards for mass spectrometry (LC-MS/MS) and other advanced analytical techniques.

Application

• Primary use as a stable isotope-labeled internal standard for the accurate quantification of dabigatran and related metabolites in biological matrices via LC-MS/MS.
• Critical component in pharmacokinetic and bioanalytical studies to understand the absorption, distribution, metabolism, and excretion (ADME) profile of dabigatran etexilate.
• Essential reference material for pharmaceutical quality control and impurity profiling during the manufacturing process of anticoagulant APIs.
• Used in method development and validation to ensure regulatory compliance (e.g., FDA, EMA) for bioanalytical assays.
• Valuable tool in metabolite identification and structural elucidation research within drug discovery pipelines.
• Supports clinical research by providing a reliable standard for therapeutic drug monitoring (TDM) studies.

Basic Information

Product Name	Deacetamidine Cyano Dabigatran-D3 Ethyl Ester
CAS No.	1346597-93-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dabigatran-D3 Ethyl Ester Intermediate; Deuterated Dabigatran Ethyl Ester; BIBR 953-D3; (3-{[(2-{[(4-Cyanophenyl)amino]methyl}-1-methyl-1H-benzimidazol-5-yl)carbonyl](pyridin-2-yl)amino}propyl-D3) ethyl ester; Ethyl 3-((2-((4-cyanobenzyl)amino)-1-methyl-1H-benzo[d]imidazole-5-carbonyl)(pyridin-2-yl)amino)propanoate-D3; BIBR 1048-D3 MS Standard
EINECS	Contact for details

Quality Control

Our deuterated reference standards are produced under strict quality management systems. Each batch undergoes comprehensive analytical characterization, including NMR, HPLC, and mass spectrometry, to confirm chemical structure, isotopic purity (D-enrichment), and chemical purity. Certificates of Analysis (COA) detailing all test results are provided and traceable to primary standards. We support compliance with ICH Q2(R1), USP, and other pharmacopeial guidelines for analytical procedures.

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, which can affect stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98 atom % D
Chemical Purity (by NMR)	Conforms
Residual Solvents (GC)	Meets ICH limits

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