Description

Ambrisentan Impurity E is a designated impurity reference standard used in the pharmaceutical development and quality control of the pulmonary arterial hypertension (PAH) drug, Ambrisentan. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by serving as a benchmark for identification and quantification. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the qualitative and quantitative analysis of Ambrisentan and related drug substances.
• Impurity Profiling & Identification: Used in HPLC, LC-MS, and other chromatographic methods to identify, characterize, and control process-related impurities and degradation products.
• Method Development & Validation: Essential for developing, validating, and transferring analytical methods in compliance with ICH Q2(R1) and other regulatory guidelines.
• Stability Studies: Employed to monitor impurity formation and degradation pathways in drug substance and product stability testing under ICH conditions.
• Quality Control (QC) Testing: Used as a system suitability and calibration standard in routine QC release testing of Ambrisentan API and finished dosage forms.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and justify specifications.

Basic Information

Product Name	Ambrisentan Impurity E
CAS No.	1312092-82-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ambrisentan Related Compound E; Ambrisentan EP Impurity E; Ambrisentan USP Impurity E; (2S)-2-[(4,6-Dimethylpyrimidin-2-yl)oxy]-3-methoxy-3,3-diphenylpropanoic Acid (proposed); Letairis Impurity E; Volibris Impurity E; Ambrisentan Degradant; Ambrisentan Process Impurity
EINECS	Contact for details

Quality Control

Our high-purity reference standards are manufactured under strict quality management systems. Each batch of Ambrisentan Impurity E (CAS 1312092-82-2) undergoes rigorous analytical testing, including HPLC for purity and spectroscopic methods for structural confirmation, to ensure it meets the exacting requirements for pharmaceutical impurity analysis. Certificates of Analysis (COA) with detailed chromatographic data, batch-specific results, and traceability are provided with every shipment.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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