Description

4,6-Dimethoxy-2-Methyl-3-Phenoxy Ambrisentan-D5 is a deuterated analog of the active pharmaceutical ingredient Ambrisentan, specifically designed for use as an internal standard in analytical chemistry. This compound matters for its critical role in ensuring the accuracy and reliability of quantitative analysis, particularly in pharmacokinetic studies and drug metabolism research. Pharmaceutical R&D laboratories, contract research organizations (CROs), and quality control departments require this high-purity reference material to meet stringent regulatory standards for method development and validation.

Application

• Internal Standard for LC-MS/MS Analysis: Primary application for the precise quantification of Ambrisentan in biological matrices like plasma and serum.
• Pharmaceutical Research & Development: Used in method development, validation, and stability studies for drug substance and product analysis.
• Bioanalytical Assays: Essential for pharmacokinetic (PK) and pharmacodynamic (PD) studies to track drug concentration over time.
• Metabolite Identification Studies: Aids in distinguishing drug-derived metabolites from endogenous compounds in complex samples.
• Quality Control & Assurance: Serves as a certified reference material for in-house QC testing of Ambrisentan APIs and finished dosage forms.
• Regulatory Submissions: Supports data packages for regulatory filings (e.g., FDA, EMA) requiring validated bioanalytical methods.

Basic Information

Product Name	4,6-Dimethoxy-2-Methyl-3-Phenoxy Ambrisentan-D5
CAS No.	1346597-40-7
Molecular Formula	C₂₂H₁₇D₅N₂O₄
Molecular Weight	379.46 g/mol
Synonyms	Ambrisentan-d5; 4,6-Dimethoxy-2-methyl-3-phenoxybenzoic acid (2,4,6-trimethyl-1,3-dioxan-5-yl)(4-propoxyphenyl)methyl-d5 amide; Deuterated Ambrisentan; (2,4,6-Trimethyl-1,3-dioxan-5-yl)[4-propoxy-2,3,5,6-d4-phenyl]methyl[2,4,6-trimethoxy-3-methyl-5-phenoxy-d-phenyl]amine; Letairis-d5 (deuterated)
EINECS	Contact for details

Quality Control

Our 4,6-Dimethoxy-2-Methyl-3-Phenoxy Ambrisentan-D5 is manufactured under strict quality systems to ensure the high chemical and isotopic purity required for analytical applications. Each batch undergoes comprehensive testing, including HPLC for chemical purity, NMR and MS for structural confirmation and deuterium enrichment, and residual solvent analysis. Certificates of Analysis (COA) detailing all specifications and test results are available upon request to support your compliance and documentation needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Deuterium Enrichment (NMR/MS)	≥ 98 atom % D
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Meets ICH guidelines

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