Description

Macitentan (n-Butyl Analogue) is a high-purity pharmaceutical intermediate and reference standard, specifically the n-butyl derivative of the endothelin receptor antagonist Macitentan. This compound is critical for research and development in medicinal chemistry, particularly for structure-activity relationship (SAR) studies and metabolic pathway investigation. It is primarily utilized by pharmaceutical R&D laboratories, academic research institutions, and manufacturers of active pharmaceutical ingredients (APIs) for the development and quality control of novel therapeutics targeting cardiovascular and pulmonary diseases.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the analytical method development and validation of Macitentan and related compounds.
• Medicinal Chemistry Research: Serves as a key intermediate and analog in SAR studies to explore the pharmacological profile and optimize the potency of endothelin receptor antagonists.
• Metabolite Synthesis & Identification: Employed in the synthesis and characterization of potential metabolites for pharmacokinetic and toxicological studies.
• Process Chemistry Development: Acts as a building block or impurity standard in the development and scale-up of synthetic routes for Macitentan API manufacturing.
• Quality Control & Assurance: Essential for impurity profiling, HPLC/LC-MS system suitability testing, and ensuring batch-to-batch consistency in API production.

Basic Information

Product Name	Macitentan (n-Butyl Analogue)
CAS No.	556797-16-1
Molecular Formula	C24H26N6O4S
Molecular Weight	494.57 g/mol
Synonyms	N-[5-(4-Bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N'-propylsulfamide; ACT-064992 n-Butyl Analogue; Macitentan n-Butyl Derivative; Macitentan Impurity; Opsumit n-Butyl Analogue; 5-(4-Bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-N-(propylsulfamoyl)-4-pyrimidinamine
EINECS	Contact for details

Quality Control

Our Macitentan (n-Butyl Analogue) is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical research and development. A detailed Certificate of Analysis (COA) with lot-specific data is provided with every shipment to guarantee traceability and compliance.

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 in a dry environment to maintain stability and purity. For long-term storage, consider desiccant use.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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