Description

Rac-Ambrisentan-D5 is a deuterated isotopologue of the endothelin receptor antagonist ambrisentan, specifically designed for use as an internal standard in analytical chemistry. This high-purity compound is essential for ensuring the accuracy and reliability of quantitative analyses, particularly in pharmacokinetic and metabolic studies. It is a critical tool for pharmaceutical R&D laboratories, contract research organizations (CROs), and quality control units requiring precise and traceable measurement of ambrisentan.

Application

• Internal Standard for LC-MS/MS: Primary application as a stable, non-interfering internal standard for the precise quantification of ambrisentan in biological matrices (plasma, serum, urine) using liquid chromatography-tandem mass spectrometry.
• Pharmacokinetic & Bioanalytical Research: Enables accurate determination of drug concentration-time profiles, bioavailability, and half-life studies during drug development and clinical trials.
• Metabolite Profiling & DMPK Studies: Used in drug metabolism and pharmacokinetics (DMPK) research to track and quantify the parent drug and its metabolites.
• Method Development & Validation: Serves as a key component in developing, optimizing, and validating robust analytical methods according to FDA, EMA, and ICH guidelines.
• Quality Control & Impurity Testing: Supports impurity profiling and assay validation of ambrisentan active pharmaceutical ingredient (API) and finished drug products.
• Forensic & Clinical Toxicology: Aids in the accurate detection and quantification of ambrisentan in specialized forensic or therapeutic drug monitoring applications.

Basic Information

Product Name	Rac-Ambrisentan-D5
CAS No.	1392210-85-3
Molecular Formula	C22H17D5N2O4
Molecular Weight	379.46 g/mol
Synonyms	Ambrisentan-d5; (±)-Ambrisentan-d5; (R,S)-Ambrisentan-d5; 2-[(4,6-Dimethylpyrimidin-2-yl)oxy]-3-methoxy-3,3-diphenyl-d5-propanoic acid; LU 208075-d5; BSF 208075-d5; Letairis-d5 (deuterated); Volibris-d5 (deuterated)
EINECS	Contact for details

Quality Control

Every batch of Rac-Ambrisentan-D5 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure exceptional quality and isotopic purity. We provide comprehensive Certificates of Analysis (COA) detailing specifications for identity, chemical purity, isotopic enrichment, and residual solvents, supporting compliance with cGMP and ICH Q3 guidelines for analytical standards. Our commitment to traceability and consistency ensures reliable performance in your most critical assays.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or CoA. This material is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider desiccation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity (D-content)	≥98 atom % D
Chemical Purity (NMR)	Conforms
Residual Solvents (GC)	Complies with ICH limits
Water Content (KF)	≤1.0%

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