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Ambrisentan Acyl β-D-Glucuronide CAS NO 1106685-58-8


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CAS No.:1106685-58-8

Grade:Pharmacy Grade

Content:99.9%

Brand:Customizable

Packaging:Customizable

Description

Ambrisentan Acyl β-D-Glucuronide is a key metabolite of the endothelin receptor antagonist ambrisentan, formed via glucuronidation. This compound is of significant importance for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics (PK), and bioanalytical method validation. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and academic institutions engaged in the development and safety assessment of ambrisentan and related therapeutic agents.

Application

  • Reference Standard for Bioanalysis: Serves as a critical certified reference material (CRM) for the quantification of ambrisentan metabolites in biological matrices using LC-MS/MS and HPLC methods.
  • Drug Metabolism and Pharmacokinetics (DMPK) Studies: Used to investigate the metabolic pathways, clearance mechanisms, and excretion profiles of ambrisentan.
  • Pharmacological Research: Aids in understanding the activity and potential interactions of ambrisentan's major circulating metabolites.
  • Impurity Profiling and Characterization: Employed as an impurity standard in the quality control of ambrisentan active pharmaceutical ingredient (API) to monitor and control related substances.
  • Toxicology and Safety Assessment: Utilized in studies to evaluate the safety and toxicological profile of ambrisentan metabolites.
  • Regulatory Submissions: Provides essential data and reference materials for regulatory filings (e.g., with FDA, EMA) supporting drug approval dossiers.

Basic Information

Product Name Ambrisentan Acyl β-D-Glucuronide
CAS No. 1106685-58-8
Molecular Formula C31H36N2O10
Molecular Weight 596.63 g/mol
Synonyms Ambrisentan Acyl Glucuronide; Ambrisentan Glucuronide; (2S)-2-[(4,6-Dimethylpyrimidin-2-yl)oxy]-3-methoxy-3,3-diphenylpropanoic acid β-D-Glucopyranuronic Acid Ester; 4-[(2S)-2-[(4,6-Dimethylpyrimidin-2-yl)oxy]-3-methoxy-3,3-diphenylpropanoyl]oxy]-5-hydroxy-6-(hydroxymethyl)oxane-2-carboxylic acid; Letairis Metabolite; Volibris Metabolite
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Quality Control

Our Ambrisentan Acyl β-D-Glucuronide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, LC-MS identification, and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided for every lot to support your research and regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry environment. This product is hygroscopic (moisture-sensitive). Allow the vial to equilibrate to room temperature in a desiccator before opening to minimize moisture uptake.

Specification

Item Specification
Appearance White to off-white solid
Identification (HPLC) Conforms
Identification (Mass Spectrometry) Conforms
Purity (HPLC) ≥ 95.0%
Water Content (KF) ≤ 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.

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