Description

Macitentan D4 is a deuterated isotopologue of the endothelin receptor antagonist Macitentan, specifically labeled with four deuterium atoms. This stable isotope-labeled compound is essential for use as an internal standard in quantitative bioanalytical methods, ensuring the highest accuracy and reliability in pharmacokinetic and metabolic studies. It is a critical tool for pharmaceutical researchers, contract research organizations (CROs), and analytical laboratories engaged in drug development and regulatory compliance for pulmonary arterial hypertension treatments.

Application

• Primary use as an Internal Standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the quantification of Macitentan in biological matrices.
• Supporting Pharmacokinetic (PK) and Bioequivalence Studies to ensure precise and accurate measurement of drug concentration levels.
• Critical component in Drug Metabolism and Pharmacokinetics (DMPK) research for metabolite profiling and identification.
• Enhancing data integrity in Clinical Trial sample analysis for pulmonary arterial hypertension (PAH) therapeutics.
• Utilized in Forensic and Anti-Doping Analysis for the definitive identification and quantification of the parent compound.
• Quality control and method development in Pharmaceutical R&D and manufacturing environments.

Basic Information

Product Name	Macitentan D4
CAS No.	1258428-05-5
Molecular Formula	C19H16D4N6O4S
Molecular Weight	416.48 g/mol
Synonyms	Macitentan-d4; N-[5-(4-Bromophenyl)-6-[2-[(2H3)methyl](2H)pyridin-4-yl]pyrimidin-4-yl]-4-(1,3-dioxoisoindol-2-yl)benzenesulfonamide; ACT-064992-d4; Opsumit-d4; 4-(1,3-Dioxo-1,3-dihydro-2H-isoindol-2-yl)-N-[5-(4-bromophenyl)-6-[2-[(2H3)methyl](2H)pyridin-4-yl]pyrimidin-4-yl]benzenesulfonamide-d4; Endothelin Receptor Antagonist-d4; Deuterated Macitentan Internal Standard
EINECS	Contact for details

Quality Control

Our Macitentan D4 is manufactured under strict quality systems to ensure it meets the exacting requirements for use as a certified reference material. Each batch undergoes comprehensive analytical testing, including NMR and Mass Spectrometry for isotopic enrichment confirmation and structural verification, and HPLC for chemical and isotopic purity assessment. Certificates of Analysis (COA) detailing batch-specific results for identity, purity, and isotopic abundance are provided and traceable to our in-house quality standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

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 (HPLC-MS)	≥ 98.0 atom % D
Chemical Purity	≥ 95.0%
Residual Solvents (GC)	Complies with 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.