Description

Bosentan Hydrate CAS NO 157212-55-0 is a high-purity, non-peptide dual endothelin receptor antagonist. This compound is a critical active pharmaceutical ingredient (API) and research standard, valued for its precise biological activity. It is primarily utilized by pharmaceutical manufacturers and advanced research institutions in the development and production of treatments for pulmonary arterial hypertension and other cardiovascular conditions.

Application

• Active Pharmaceutical Ingredient (API): Serves as the core component in the formulation of finished dosage forms for pulmonary arterial hypertension (PAH) therapy.
• Reference Standard: Used in analytical laboratories for method development, validation, and quality control testing of pharmaceutical products.
• Biochemical Research: A vital tool for studying endothelin receptor pathways, signal transduction, and vascular biology in preclinical research.
• Pharmaceutical Development: Employed in formulation studies, stability testing, and the development of generic drug products.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for cGMP production of clinical and commercial drug supplies.

Basic Information

Product Name	Bosentan Hydrate
CAS No.	157212-55-0
Molecular Formula	C27H29N5O6S • xH2O
Molecular Weight	551.62 g/mol (anhydrous basis)
Synonyms	Bosentan Monohydrate; 4-tert-Butyl-N-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-(pyrimidin-2-yl)pyrimidin-4-yl]benzenesulfonamide hydrate; Ro 47-0203; Tracleer (brand name, API); Endothelin Receptor Antagonist; BOS; BSF 208075
EINECS	Contact for details

Quality Control

Our Bosentan Hydrate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identification by IR and NMR spectroscopy, and tests for residual solvents and related substances to ensure compliance with ICH guidelines. A Certificate of Analysis (COA) detailing all specifications and results is provided with every shipment to guarantee traceability and supply chain reliability.

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 material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.5% (on anhydrous basis)
Water Content (KF)	3.0% - 6.0%
Related Substances (HPLC)	Total impurities ≤1.5% Any single impurity ≤0.5%
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.