Description

Bosentan CAS NO 147536-97-8 is a potent and selective dual endothelin receptor antagonist (ERA) used as an active pharmaceutical ingredient (API). This compound is critical for the development and production of medications targeting pulmonary arterial hypertension (PAH), a severe and progressive vascular disorder. It is essential for pharmaceutical manufacturers, research institutions, and contract development and manufacturing organizations (CDMOs) engaged in cardiovascular drug formulation and advanced therapeutic research.

Application

• Pharmaceutical API: Primary use as the active ingredient in finished dosage forms for the treatment of pulmonary arterial hypertension (PAH).
• Reference Standard: Serves as a high-purity chemical standard for analytical method development, validation, and quality control testing in regulatory submissions.
• Research & Development: Utilized in preclinical and clinical research to study endothelin pathways, vascular biology, and potential new therapeutic applications.
• Formulation Development: Key component in the development of various drug delivery systems, including tablets and other oral solid dosage forms.
• Contract Manufacturing: Supplied to CDMOs for the commercial-scale production of generic and branded pharmaceutical products.

Basic Information

Product Name	Bosentan
CAS No.	147536-97-8
Molecular Formula	C27H29N5O6S
Molecular Weight	551.61 g/mol
Synonyms	4-tert-Butyl-N-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-(pyrimidin-2-yl)pyrimidin-4-yl]benzenesulfonamide; Tracleer (Brand Name); Ro 47-0203; Bosentan Monohydrate; BOS; Endothelin Receptor Antagonist
EINECS	Contact for details

Quality Control

Our Bosentan is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity standards suitable for pharmaceutical applications. We provide full traceability and support regulatory filings with detailed documentation. Certificates of Analysis (COA) are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm

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