Description

Candesartan-D5 Methyl Ester CAS NO 1216502-48-5 is a deuterated, isotopically labeled analog of the angiotensin II receptor antagonist Candesartan, specifically designed for use as an internal standard in quantitative analytical methods. This high-purity compound is essential for ensuring the accuracy and reliability of mass spectrometry-based analyses in pharmaceutical research and development. It is primarily utilized by analytical chemists and researchers in pharmaceutical companies, contract research organizations (CROs), and regulatory testing laboratories for pharmacokinetic studies, bioequivalence testing, and metabolite identification.

Application

• Internal Standard for LC-MS/MS: Serves as a critical internal standard for the precise quantification of Candesartan and its metabolites in complex biological matrices such as plasma, serum, and urine.
• Pharmaceutical R&D: Used in method development and validation for pharmacokinetic (PK) and pharmacodynamic (PD) studies during drug development.
• Bioanalytical Assays: Enables accurate measurement of drug concentration in bioequivalence and bioavailability studies, ensuring regulatory compliance.
• Metabolite Profiling: Aids in the identification and quantification of drug metabolites in metabolism and disposition studies.
• Quality Control in Manufacturing: Can be employed in analytical methods for quality control of active pharmaceutical ingredients (APIs) and finished drug products.
• Clinical Research: Supports therapeutic drug monitoring and clinical trial sample analysis to ensure data integrity.

Basic Information

Product Name	Candesartan-D5 Methyl Ester
CAS No.	1216502-48-5
Molecular Formula	C25H25D5N6O3
Molecular Weight	447.55 g/mol (for deuterated form)
Synonyms	2-Ethoxy-1-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1H-benzimidazole-7-carboxylic Acid Methyl Ester-d5; (2-Ethoxy-1-((2'-(1H-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)-1H-benzo[d]imidazole-7-carboxylic Acid Methyl Ester-d5); Candesartan Methyl Ester-d5; Candesartan cilexetil impurity D5 methyl ester; Isotopically Labeled Candesartan Methyl Ester; TCV-116-d5 Methyl Ester; AT1 antagonist-d5 methyl ester
EINECS	Contact for details

Quality Control

Our Candesartan-D5 Methyl Ester is manufactured under strict quality control protocols to ensure the highest standards of isotopic purity and chemical integrity, suitable for sensitive analytical applications. Each batch is analyzed to confirm identity, purity, and isotopic enrichment. Certificates of Analysis (COA) are provided, detailing results from advanced chromatographic and spectroscopic methods. We support 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 (15-25°C) or as indicated on the label. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccant in the container.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-content)	≥ 98.0 atom % D
Chemical Purity	≥ 95.0%
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.