Description

Ambrisentan CAS NO 713516-99-5 is a potent and selective endothelin receptor antagonist (ERA) of the endothelin-A (ETA) subtype. This high-purity active pharmaceutical ingredient (API) is critical for the development and manufacturing of targeted pulmonary arterial hypertension (PAH) therapies. It is essential for pharmaceutical companies, research institutions, and contract manufacturing organizations (CMOs) engaged in the production of innovative cardiovascular medications.

Application

• Pharmaceutical API: Primary active ingredient in the commercial production of oral tablets for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1).
• Clinical Research Material: Serves as a reference standard and raw material for clinical trials investigating new PAH treatments or combination therapies.
• Formulation Development: Used in R&D laboratories for developing novel drug delivery systems, such as controlled-release formulations.
• Analytical Reference Standard: Employed in quality control (QC) and analytical method development (HPLC, LC-MS) for identity, assay, and impurity profiling.
• Biochemical Research: A key tool for in-vitro and in-vivo studies exploring the endothelin signaling pathway and its role in vascular diseases.
• Generic Drug Manufacturing: Critical starting material for companies producing bioequivalent versions of approved ambrisentan medications.

Basic Information

Product Name	Ambrisentan
CAS No.	713516-99-5
Molecular Formula	C22H22N2O4
Molecular Weight	378.42 g/mol
Synonyms	Ambrisentan; BSF 208075; LU 208075; (+)-(2S)-2-[(4,6-Dimethylpyrimidin-2-yl)oxy]-3-methoxy-3,3-diphenylpropanoic acid; 2-[(4,6-Dimethylpyrimidin-2-yl)oxy]-3-methoxy-3,3-diphenylpropanoic acid; Letairis (Brand Name); Volibris (Brand Name); Pulmonext
EINECS	Contact for details

Quality Control

Our Ambrisentan is manufactured under strict quality management systems to ensure it meets the stringent requirements for pharmaceutical use. Every batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We adhere to relevant ICH guidelines and can support documentation for regulatory submissions (e.g., DMF, CEP).

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 should be handled 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%
Related Substances (HPLC)	Total impurities ≤1.5% Any single unknown impurity ≤0.10%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.