Description

2H-2-Ethyl-D5 Candesartan Cilexetil is a deuterated analog of the active pharmaceutical ingredient candesartan cilexetil, a potent angiotensin II receptor blocker (ARB). This stable isotope-labeled compound is essential for use as an internal standard in quantitative bioanalytical methods, ensuring the highest accuracy and reliability in pharmacokinetic and metabolic studies. It is a critical material for pharmaceutical R&D laboratories, contract research organizations (CROs), and manufacturers developing or validating analytical assays for this important cardiovascular drug.

Application

• Internal Standard for LC-MS/MS: Primary application as a high-purity, non-interfering internal standard in liquid chromatography-tandem mass spectrometry (LC-MS/MS) for the precise quantification of candesartan and its metabolites in biological matrices.
• Drug Metabolism and Pharmacokinetics (DMPK): Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles in preclinical and clinical studies.
• Bioanalytical Method Development & Validation: Serves as a critical reference material for developing, optimizing, and validating robust analytical methods in compliance with FDA, EMA, and ICH guidelines.
• Clinical Trial Support: Used in bioanalysis for therapeutic drug monitoring and pharmacokinetic assessments during clinical trials of candesartan-based therapies.
• Reference Standard for Impurity Testing: Can be utilized as a reference marker in stability-indicating methods to identify and quantify related substances or degradation products.

Basic Information

Product Name	2H-2-Ethyl-D5 Candesartan Cilexetil
CAS No.	1246816-44-3
Molecular Formula	C33H29D5N6O6
Molecular Weight	615.68 g/mol (for deuterated form)
Synonyms	2-Ethyl-d5 Candesartan Cilexetil; Candesartan Cilexetil-d5; Candesartan Cilexetil (2-ethyl-d5); (±)-1-Hydroxyethyl 2-ethoxy-1-[[2'-(2H5-1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1H-benzimidazole-7-carboxylate; TCV-116-d5; Atacand-d5 (deuterated analog); (2-Ethyl-d5)-Candesartan Cilexetil; Deuterated Candesartan Cilexetil Internal Standard
EINECS	Contact for details

Quality Control

Our deuterated standards are produced under strict quality management systems to ensure the high chemical purity and isotopic enrichment required for sensitive analytical applications. Each batch is characterized by advanced spectroscopic and chromatographic techniques, including NMR, HPLC, and mass spectrometry. A comprehensive Certificate of Analysis (COA) is provided, detailing assay, isotopic purity, chemical purity, and identification data, supporting compliance with ICH Q2(R1) guidelines for analytical method validation.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. For long-term stability, storage at -20°C is recommended. The product is light-sensitive (store away from light).

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-content)	≥ 98 atom % D
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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