Description

Ambrisentan Impurity 3 is a designated pharmaceutical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Ambrisentan, an endothelin receptor antagonist. It is primarily required by pharmaceutical manufacturers and analytical laboratories for method development, validation, and routine quality control testing. The availability of well-characterized impurities like this is essential for regulatory compliance and maintaining high standards in drug production.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Ambrisentan API and its finished dosage forms.
• Method Development & Validation: Used in developing and validating chromatographic methods (HPLC, UPLC) for impurity profiling and stability studies.
• Quality Control (QC) Testing: Employed as a system suitability and identification marker in the routine QC testing of Ambrisentan batches to monitor impurity levels against established specifications.
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require complete impurity characterization and control strategies.
• Stability Studies: Used to identify and quantify degradation products that may form under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Supports R&D activities focused on understanding the degradation pathways and metabolism of Ambrisentan.

Basic Information

Product Name	Ambrisentan Impurity 3
CAS No.	178306-49-5
Molecular Formula	C22H22N2O4
Molecular Weight	378.42 g/mol
Synonyms	Ambrisentan Related Compound C; (2S)-2-[(4,6-Dimethylpyrimidin-2-yl)oxy]-3-methoxy-3,3-diphenylpropanoic Acid; 3-Methoxy-3,3-diphenyl-2-((4,6-dimethylpyrimidin-2-yl)oxy)propanoic Acid; Propanoic acid, 3-methoxy-3,3-diphenyl-2-[(4,6-dimethyl-2-pyrimidinyl)oxy]-, (2S)-; Ambrisentan EP Impurity C; Ambrisentan USP Impurity C
EINECS	Contact for details

Quality Control

Our Ambrisentan Impurity 3 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with major pharmacopeial standards (USP, EP) and ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5%

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