Description

Deacetamidine Cyano Dabigatran-D3 Ethyl Ester Oxalate is a high-purity, deuterium-labeled chemical reference standard of critical importance in modern analytical chemistry. This compound is specifically designed to serve as an internal standard in quantitative bioanalytical methods, ensuring the highest levels of accuracy and reliability in sensitive measurements. It is an essential tool for pharmaceutical researchers, analytical laboratories, and contract research organizations (CROs) engaged in drug metabolism, pharmacokinetic (PK) studies, and clinical trial sample analysis.

Application

• Internal Standard for LC-MS/MS Analysis: Primary application as a stable, isotopically labeled internal standard for the precise quantification of Dabigatran and its metabolites in complex biological matrices like plasma and serum.
• Pharmaceutical R&D: Critical for method development and validation in pharmacokinetic (PK) and pharmacodynamic (PD) studies during the drug development process.
• Clinical Trial Support: Enables accurate measurement of drug concentration in patient samples for bioavailability, bioequivalence, and therapeutic drug monitoring studies.
• Metabolite Identification & Profiling: Aids in the structural elucidation and tracking of drug metabolites using mass spectrometry.
• Regulatory Compliance Testing: Supports analytical testing required for regulatory submissions to agencies like the FDA and EMA, where method accuracy is paramount.
• Quality Control in Manufacturing: Used in the quality control of active pharmaceutical ingredients (APIs) and finished drug products to ensure batch consistency and purity.

Basic Information

Product Name	Deacetamidine Cyano Dabigatran-D3 Ethyl Ester Oxalate
CAS No.	1794780-07-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dabigatran-D3 Ethyl Ester Oxalate; Dabigatran D3 Ethyl Ester; BIBR 953-D3 Ethyl Ester Oxalate; 3-[[2-[[[4-[[(Hexyloxy)carbonyl]amino]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl](pyridin-2-yl)amino-D3 Ethyl Propanoate Oxalate; (R)-N-(2-(4-(N-(Hexyloxycarbonyl)carbamimidoyl)phenylamino)methyl)-1-methyl-1H-benzo[d]imidazole-5-carbonyl)-N-(pyridin-2-yl)-β-alanine-D3 Ethyl Ester Oxalate
EINECS	Contact for details

Quality Control

Every batch of Deacetamidine Cyano Dabigatran-D3 Ethyl Ester Oxalate is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity, purity, and isotopic enrichment verification using advanced analytical techniques including NMR, HPLC, and Mass Spectrometry to ensure it meets the exacting standards required for use as a certified reference material. A comprehensive Certificate of Analysis (COA) detailing batch-specific results for purity, isotopic purity (D-enrichment), and residual solvents is provided with each shipment.

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 product is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC-MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98.0 atom % D
Chemical Purity (NMR)	Conforms
Residual Solvents (GC)	Meets ICH guidelines
Water Content (KF)	≤ 1.0%

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