Description

Azilsartan-D5 is a stable isotope-labeled analog of the antihypertensive drug Azilsartan, specifically deuterated at five positions. This high-purity compound is an essential internal standard for the accurate quantification of Azilsartan in complex biological matrices using advanced analytical techniques like LC-MS/MS. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in pharmacokinetic studies, bioequivalence testing, and drug metabolism research.

Application

• Internal Standard for Bioanalysis: Serves as a critical reference standard in the quantitative LC-MS/MS analysis of Azilsartan in plasma, serum, and urine for pharmacokinetic (PK) and pharmacodynamic (PD) studies.
• Drug Metabolism and Pharmacokinetics (DMPK): Enables precise tracking and measurement of the parent drug in absorption, distribution, metabolism, and excretion (ADME) studies.
• Clinical Research & Bioequivalence Testing: Used to ensure accuracy and reproducibility in studies comparing branded and generic formulations of Azilsartan medoxomil.
• Pharmaceutical Quality Control: Supports method development and validation for the impurity profiling and assay of Azilsartan in active pharmaceutical ingredient (API) and finished dosage forms.
• Forensic & Anti-Doping Analysis: Applicable in specialized testing environments for the definitive identification and quantification of the substance.

Basic Information

Product Name	Azilsartan-D5
CAS No.	1346599-45-8
Molecular Formula	C25H15D5N4O5
Molecular Weight	~ 453.46 g/mol
Synonyms	2-Ethoxy-1-[[2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)[1,1'-biphenyl]-4-yl]methyl]-1H-benzimidazole-7-carboxylic Acid-d5; (5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 2-ethoxy-1-[[2'-(5-oxo-4H-1,2,4-oxadiazol-3-yl)[1,1'-biphenyl]-4-yl]methyl]benzimidazole-7-carboxylate-d5; TAK-536-d5; Edarbi-d5; Azilsartan (deuterated, 5 positions); Azilsartan Internal Standard-d5
EINECS	Contact for details

Quality Control

Our Azilsartan-D5 is manufactured under strict quality control protocols to ensure the high chemical purity and isotopic enrichment required for sensitive analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results for identity, purity (by HPLC), isotopic purity, and residual solvents. We support compliance with ICH guidelines for analytical method validation.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Isotopic Purity	≥ 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.