Description

1H-1-Ethyl-D5 Candesartan is a deuterated isotopologue of the active pharmaceutical ingredient Candesartan, a potent angiotensin II receptor antagonist. This deuterium-labeled compound is specifically designed for use as an internal standard in quantitative bioanalytical methods, ensuring unparalleled accuracy and reliability in pharmacokinetic and metabolism studies. It is an essential tool for pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers engaged in drug development and regulatory compliance testing.

Application

• Bioanalytical Internal Standard: Primary use as a stable, isotopically labeled internal standard for the precise quantification of Candesartan and its metabolites in biological matrices (e.g., plasma, serum, urine) via LC-MS/MS.
• Drug Metabolism and Pharmacokinetics (DMPK): Critical for conducting accurate absorption, distribution, metabolism, and excretion (ADME) studies during preclinical and clinical development phases.
• Method Development and Validation: Serves as a reference material for developing, optimizing, and validating robust analytical methods in compliance with FDA, EMA, and ICH guidelines.
• Clinical Trial Support: Enables reliable therapeutic drug monitoring and pharmacokinetic profiling in human clinical trials for antihypertensive medications.
• Forensic and Doping Analysis: Used in specialized laboratories for the confirmatory analysis of pharmaceutical substances.
• Manufacturing Process Control: Can be utilized in quality control laboratories for trace analysis and impurity profiling of Candesartan drug substance and products.

Basic Information

Product Name	1H-1-Ethyl-D5 Candesartan
CAS No.	1246818-70-1
Molecular Formula	C24H15D5N6O3
Molecular Weight	~ 440.48 g/mol
Synonyms	Candesartan-d5 (1-Ethyl-d5); 2-Ethoxy-1-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1H-benzimidazole-7-carboxylic Acid (1-Ethyl-d5); (±)-1-Hydroxy-1-ethyl-d5 Ethyl Candesartan; TCV-116-d5; CV-11974-d5; BLI-1497-d5; Deuterated Candesartan Internal Standard
EINECS	Contact for details

Quality Control

Our deuterated standards are manufactured under strict quality systems to ensure the highest levels of chemical purity, isotopic enrichment, and batch-to-batch consistency. Each lot is characterized using advanced analytical techniques including NMR (for deuterium incorporation), HPLC, and mass spectrometry. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, isotopic purity, and analytical results. Production adheres to relevant ISO standards, supporting our commitment to reliable and traceable reference materials for the global life sciences industry.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the product label or COA. The product is light-sensitive and should be stored away from direct light exposure. Keep the container tightly sealed in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Purity (deuterium incorporation)	≥ 98 atom % D
Chemical Purity (by NMR)	≥ 97.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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