Description

Ambrisentan D3 is a deuterated internal standard of the pulmonary arterial hypertension drug, Ambrisentan, specifically designed for analytical and research applications. This stable isotope-labeled compound is essential for ensuring the accuracy and reliability of quantitative mass spectrometry analyses, such as LC-MS/MS, by correcting for variations in sample preparation and instrument response. It is a critical tool for pharmaceutical researchers, clinical laboratories, and regulatory bodies engaged in drug metabolism and pharmacokinetic (DMPK) studies, bioanalytical method development, and therapeutic drug monitoring.

Application

• Quantitative Bioanalysis: Serves as an internal standard for the precise quantification of Ambrisentan in biological matrices (plasma, serum, urine) using LC-MS/MS.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables accurate measurement of drug concentration-time profiles to understand absorption, distribution, metabolism, and excretion.
• Clinical Research: Supports therapeutic drug monitoring and clinical trial sample analysis for pulmonary arterial hypertension treatments.
• Drug Metabolism Studies: Used in in vitro and in vivo studies to investigate metabolic pathways and identify metabolites.
• Method Development and Validation: A key component in developing and validating robust, GLP/GCP-compliant bioanalytical assays.
• Quality Control in Manufacturing: Can be utilized in impurity profiling and stability testing of pharmaceutical formulations.

Basic Information

Product Name	Ambrisentan D3
CAS No.	1046116-26-0
Molecular Formula	C22H19D3N2O4
Molecular Weight	381.44 g/mol
Synonyms	Ambrisentan-d3; (2S)-2-[(4,6-Dimethylpyrimidin-2-yl)oxy]-3-methoxy-3,3-bis(4-methoxyphenyl-d3)propanoic acid; BSF 208075-d3; LU 208075-d3; Volibris-d3; Letairis-d3; Deuterated Ambrisentan; Ambrisentan Internal Standard
EINECS	Contact for details

Quality Control

Our Ambrisentan D3 is manufactured under strict quality control protocols to ensure the high chemical and isotopic purity required for sensitive analytical applications. Each batch is characterized by advanced spectroscopic and chromatographic techniques, including NMR, HPLC, and MS, to confirm identity, purity, and isotopic enrichment. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment, supporting compliance with GLP and research standards.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below for long-term stability. For short-term use, the material may be stored at 2-8°C. The product is hygroscopic (moisture-sensitive); allow the sealed vial to equilibrate to room temperature before opening to minimize moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to expected mass spectrum
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 99.0 atom % D
Chemical Purity (NMR)	Conforms to structure
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Meets ICH guidelines

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