Description

Bosentan Acetate is the acetate salt form of bosentan, a potent and competitive dual endothelin receptor antagonist. This high-purity active pharmaceutical ingredient (API) is critical for ensuring the efficacy and safety of finished pharmaceutical formulations. It is primarily utilized by pharmaceutical manufacturers and research institutions engaged in the development and production of treatments for pulmonary arterial hypertension (PAH) and other cardiovascular conditions.

Application

• Pharmaceutical API: Primary use as the active ingredient in the manufacture of solid oral dosage forms (e.g., tablets) for the treatment of pulmonary arterial hypertension (PAH).
• Reference Standard: Serves as a certified reference material (CRM) for analytical method development, validation, and quality control testing in pharmaceutical laboratories.
• Clinical Research: Used in preclinical and clinical studies investigating new therapeutic applications for endothelin receptor antagonism.
• Formulation Development: Employed in R&D for developing novel drug delivery systems and optimizing the stability and bioavailability of bosentan-based medications.

Basic Information

Product Name	Bosentan Acetate
CAS No.	1160515-46-7
Molecular Formula	C29H32N2O7S • C2H4O2
Molecular Weight	588.66 g/mol (for Bosentan Acetate)
Synonyms	Bosentan monoacetate; 4-tert-Butyl-N-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-(pyrimidin-2-yl)pyrimidin-4-yl]benzenesulfonamide acetate; Tracleer Acetate; Ro 47-0203 acetate; (2S)-N-[6-(2-Hydroxyethoxy)-5-(2-methoxyphenoxy)-2-(2-pyrimidinyl)-4-pyrimidinyl]-4-(1,1-dimethylethyl)benzenesulfonamide acetate
EINECS	Contact for details

Quality Control

Our Bosentan Acetate 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 guidelines. A Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and other critical parameters 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 controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and purity.

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)
Related Substances (HPLC)	Total impurities ≤ 1.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm

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