Description

Ambrisentan Impurity 7 is a designated reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Ambrisentan. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Ambrisentan API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurities.
• Quality Control & Assurance (QC/QA): A critical component in routine batch release testing to ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B guidelines).
• Stability Studies: Employed to track the formation of degradation products in Ambrisentan under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to synthesize purer batches of the API.

Basic Information

Product Name	Ambrisentan Impurity 7
CAS No.	80532-84-9
Molecular Formula	C22H22N2O4
Molecular Weight	378.43 g/mol
Synonyms	Ambrisentan Related Compound 7; (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; Ambrisentan EP Impurity G; Ambrisentan USP Impurity 7; Letairis Impurity 7; Volibris Impurity 7
EINECS	Contact for details

Quality Control

Every batch of Ambrisentan Impurity 7 is manufactured and handled under strict quality management systems. Our products undergo rigorous identity, purity, and strength testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results against established specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing at 2-8°C.

Specification

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

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