Description

Betrixaban D6 is a deuterium-labeled isotopologue of the direct Factor Xa inhibitor Betrixaban, serving as a critical internal standard for precise quantitative analysis. This high-purity reference material is essential for ensuring accuracy and reliability in pharmacokinetic and metabolism studies, particularly in regulated bioanalytical method development. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in advanced drug development and clinical research.

Application

• Internal Standard for LC-MS/MS: Used as a stable isotope-labeled internal standard in Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) for the accurate quantification of Betrixaban in biological matrices (e.g., plasma, serum).
• Bioanalytical Method Development and Validation: Critical for developing, validating, and transferring robust analytical methods in compliance with FDA, EMA, and ICH guidelines.
• Pharmacokinetic (PK) and Pharmacodynamic (PD) Studies: Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical trials.
• Metabolite Identification and Profiling: Aids in distinguishing drug-derived metabolites from endogenous compounds in mass spectrometry-based studies.
• Doping Control and Forensic Analysis: Employed in confirmatory testing for prohibited substances where high specificity and accuracy are required.
• Quality Control in Pharmaceutical Manufacturing: Supports in-process testing and final product release testing for Betrixaban-based drug products.

Basic Information

Product Name	Betrixaban D6
CAS No.	2098655-51-5
Molecular Formula	C23H26D6N4O4
Molecular Weight	428.55 g/mol (approximate)
Synonyms	Betrixaban-d6; N-(5-Chloropyridin-2-yl)-2-[4-(N,N-dimethylcarbamimidoyl)benzamido]-5-methoxybenzamide-d6; 1-(5-Chloro-2-pyridinyl)-N-[2-[4-[(dimethylamino)iminomethyl]benzoyl]amino]-4-methoxyphenyl]-3-(trideuteriomethyl)-1H-pyrazole-5-carboxamide; BMS-561389-d6; PRT-054021-d6; LY-517717-d6; DU-176b-d6
EINECS	Contact for details

Quality Control

Our Betrixaban D6 is manufactured under strict quality systems to ensure the highest standards of purity and isotopic enrichment required for analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results for identity, chemical purity (by HPLC), isotopic purity (by MS), and residual solvents. We support compliance with ICH Q2(R1) and other relevant regulatory guidelines for bioanalytical method validation.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (MS)	≥ 98.0 atom % D
Chemical Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH limits

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