Description

Hydroxy Bosentan-D4 is a high-purity, stable isotope-labeled analog of the active metabolite of Bosentan, a dual endothelin receptor antagonist. This deuterated compound is an essential internal standard for the precise quantification of its parent drug and metabolites in complex biological matrices using advanced analytical techniques. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and bioanalytical facilities engaged in pharmacokinetic studies, drug metabolism research, and clinical trial support.

Application

• Bioanalytical Reference Standard: Serves as a critical internal standard in LC-MS/MS and GC-MS methods for the accurate quantification of Bosentan and its metabolites in plasma, serum, and urine.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles in preclinical and clinical research.
• Clinical Trial Analysis: Supports robust and validated bioanalytical assays required for monitoring drug levels in patients during clinical development phases.
• Forensic and Doping Control: Used in specialized laboratories for the confirmatory analysis of pharmaceutical substances.
• Pharmaceutical Impurity Profiling: Aids in the identification and characterization of related substances and degradation products in drug substance and product development.
• Isotope Dilution Mass Spectrometry (IDMS): Provides the highest accuracy in quantitative analysis due to its nearly identical chemical properties to the analyte.

Basic Information

Product Name	Hydroxy Bosentan-D4
CAS No.	1065472-91-4
Molecular Formula	C27H25D4N5O6S
Molecular Weight	~ 555.62 g/mol
Synonyms	Bosentan Hydroxy Metabolite-d4; 4-(1,1-Dimethylethyl)-N-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-(pyrimidin-2-yl)-4-pyrimidinyl]benzenesulfonamide-d4; (2R,3S,4R,5R)-5-(4-Aminopyrrolo[2,1-f][1,2,4]triazin-7-yl)-5-cyano-3,4-dihydroxytetrahydrofuran-2-yl methyl phosphate-d4; Deuterated Hydroxy Bosentan; Bosentan Metabolite-d4; RO 47-0203 Metabolite-d4; Tracleer Metabolite-d4
EINECS	Contact for details

Quality Control

Every batch of Hydroxy Bosentan-D4 is manufactured under strict quality management systems and undergoes comprehensive analytical characterization to ensure identity, purity, and isotopic enrichment. Our products are supplied with a comprehensive Certificate of Analysis (COA) detailing results for assay, isotopic purity (D-enrichment), and related substances by HPLC. We support compliance with ICH Q2(R1) guidelines for analytical method validation and can provide materials suitable for use in GLP/GMP-regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry, cool place. This product is hygroscopic (moisture-sensitive). Allow the sealed vial to equilibrate to room temperature before opening to minimize moisture absorption.

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 (D-enrichment)	≥ 98.0 atom % D
Chemical Purity (NMR)	Conforms
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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