Description

Rac Ambrisentan-D3 Methyl Ester CAS NO 1329837-75-3 is a deuterated isotopologue of the Ambrisentan methyl ester derivative, serving as a critical stable isotope-labeled internal standard for analytical quantification. This compound is essential for ensuring the accuracy and reliability of pharmacokinetic and bioanalytical studies, particularly in drug metabolism and pharmacodynamics (DMPK) research. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers involved in the development and quality control of endothelin receptor antagonists.

Application

• Primary use as an internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) and High-Performance Liquid Chromatography (HPLC) methods for the quantification of Ambrisentan and related metabolites.
• Critical component in bioanalytical method development and validation for clinical and preclinical studies.
• Supporting drug metabolism and pharmacokinetic (DMPK) research to understand the absorption, distribution, metabolism, and excretion (ADME) profile of therapeutic agents.
• Used in pharmaceutical quality control laboratories for impurity profiling and assay verification of active pharmaceutical ingredients (APIs).
• Facilitates regulatory compliance for submissions to agencies like the FDA and EMA by providing traceable and consistent analytical data.
• Essential for isotope dilution mass spectrometry techniques, enhancing the precision of quantitative analysis in complex biological matrices.

Basic Information

Product Name	Rac Ambrisentan-D3 Methyl Ester
CAS No.	1329837-75-3
Molecular Formula	C₂₀H₁₆D₃NO₄
Molecular Weight	334.38 g/mol
Synonyms	Ambrisentan-d3 Methyl Ester; (2S)-2-[(4,6-Dimethylpyrimidin-2-yl)oxy]-3-methoxy-3,3-dideuterio-3-phenyl-d-propanoic Acid Methyl Ester; Methyl 2-[(4,6-dimethylpyrimidin-2-yl)oxy]-3-methoxy-3,3-dideuterio-3-phenylpropanoate-d3; Rac-Deutero Ambrisentan Methyl Ester; Deuterated Ambrisentan Methyl Ester; Internal Standard for Ambrisentan; Isotopically Labeled Ambrisentan Ester
EINECS	Contact for details

Quality Control

Every batch of Rac Ambrisentan-D3 Methyl Ester is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure high chemical purity and isotopic enrichment. Our quality assurance protocol includes comprehensive characterization by NMR, HPLC, and mass spectrometry. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting purity, isotopic purity (D-enrichment), and confirming the absence of unlabeled species. We adhere to cGMP principles where applicable to support its use in regulated bioanalytical environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This product is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere to ensure stability.

Specification

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

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