Description

Macitentan is a potent, orally active dual endothelin receptor antagonist (ERA) used in the treatment of pulmonary arterial hypertension (PAH). Its primary value lies in its ability to improve long-term outcomes by delaying disease progression and reducing hospitalization rates. This high-purity active pharmaceutical ingredient (API) is essential for pharmaceutical manufacturers engaged in the development and production of innovative cardiovascular therapeutics.

Application

• Active Pharmaceutical Ingredient (API) in the formulation of oral medications for Pulmonary Arterial Hypertension (PAH).
• Key component in clinical research and development of novel endothelin receptor antagonist therapies.
• Reference standard for analytical method development and quality control in pharmaceutical laboratories.
• Starting material or intermediate for the synthesis of related chemical entities in medicinal chemistry.

Basic Information

Product Name	Macitentan
CAS No.	441798-33-0
Molecular Formula	C19H20Br2N6O4S
Molecular Weight	588.27 g/mol
Synonyms	ACT-064992; N-[5-(4-Bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N'-propylsulfamide; Opsumit (Brand Name); Macitentanum; TBC-3711
EINECS	Contact for details

Quality Control

Our Macitentan is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, aligning with ICH Q7 guidelines for active pharmaceutical ingredients. A detailed Certificate of Analysis (COA) 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). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	≥ 98.5%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Loss on Drying	≤ 0.5%
Heavy Metals	≤ 20 ppm

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