Description

4-Hydroxymethyl Ambrisentan Acyl Glucuronide is a key metabolite and reference standard of the active pharmaceutical ingredient Ambrisentan. This compound is of critical importance for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics, and bioanalytical method validation. It is primarily utilized by pharmaceutical companies, contract research organizations (CROs), and academic institutions engaged in the development and quality control of pulmonary arterial hypertension (PAH) therapeutics.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the quantification and identification of the 4-hydroxymethyl metabolite in biological matrices during clinical and non-clinical studies.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Essential for investigating the metabolic pathways, clearance mechanisms, and exposure levels of Ambrisentan and its metabolites.
• Bioanalytical Method Development & Validation: Used as a critical calibrator and quality control sample in LC-MS/MS and HPLC methods to ensure accurate and reproducible assay performance.
• Impurity Profiling and Characterization: Employed to identify, monitor, and control process-related and degradation impurities in Ambrisentan drug substance and finished dosage forms.
• Regulatory Submissions: Provides essential data to support Investigational New Drug (IND) and New Drug Application (NDA) filings with regulatory bodies like the FDA and EMA.
• Stability Testing: Used as a marker to assess the stability of Ambrisentan formulations under various storage conditions.

Basic Information

Item	Details
Product Name	4-Hydroxymethyl Ambrisentan Acyl Glucuronide
CAS No.	1106685-77-1
Molecular Formula	C30H34N2O11
Molecular Weight	598.60 g/mol
Synonyms	Ambrisentan 4-Hydroxymethyl Acyl Glucuronide; Ambrisentan Metabolite M4 Acyl Glucuronide; (2S)-2-[(4,6-Dimethylpyrimidin-2-yl)oxy]-3-methoxy-3,3-diphenylpropanoic acid 4-(hydroxymethyl)phenyl ester β-D-glucopyranosiduronic acid; Letairis Metabolite Glucuronide; Volibris Metabolite Glucuronide; BSF 208075 Metabolite M4 Glucuronide
EINECS	Contact for details

Quality Control

Our 4-Hydroxymethyl Ambrisentan Acyl Glucuronide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity analysis, LC-MS identity confirmation, and residual solvent screening to ensure it meets the stringent requirements for pharmaceutical reference standards. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry, controlled environment. Due to its hygroscopic (moisture-sensitive) nature, the container should be allowed to equilibrate to room temperature before opening to prevent condensation. For long-term storage, consider storage under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC/MS)	Conforms to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Meets ICH Q3C guidelines

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