Description

Irbesartan-D3 is a deuterium-labeled analog of the angiotensin II receptor antagonist, Irbesartan. 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 tool for pharmaceutical R&D laboratories, clinical research organizations, and analytical service providers engaged in drug development and therapeutic monitoring.

Application

• Internal Standard for LC-MS/MS: Primary application as a quantitative internal standard in Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) for the precise measurement of Irbesartan in biological matrices.
• Pharmacokinetic Studies: Enables accurate determination of drug absorption, distribution, metabolism, and excretion (ADME) profiles in preclinical and clinical trials.
• Bioequivalence Testing: Critical for comparative studies between generic and brand-name formulations to ensure therapeutic equivalence.
• Metabolite Profiling: Aids in the identification and quantification of Irbesartan metabolites in complex biological samples.
• Therapeutic Drug Monitoring (TDM): Supports the development and validation of robust assays for monitoring drug concentrations in patient plasma or serum.
• Method Development & Validation: Serves as a key reference material for developing, optimizing, and validating new analytical protocols in compliance with regulatory guidelines (e.g., FDA, EMA).

Basic Information

Product Name	Irbesartan-D3
CAS No.	1185120-76-6
Molecular Formula	C25H25D3N6O
Molecular Weight	432.55 g/mol
Synonyms	2-Butyl-3-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1,3-diazaspiro[4.4]non-1-en-4-one-d3; Irbesartan (phenyl-d3); 2-n-Butyl-3-[(2'-(1H-tetrazol-5-yl)biphenyl-4-yl)methyl]-1,3-diazaspiro[4.4]non-1-en-4-one-d3; BMS-186295-d3; SR 47436-d3; Avapro-d3 (labeled); Deuterated Irbesartan
EINECS	Contact for details

Quality Control

Every batch of Irbesartan-D3 is manufactured and analyzed under strict quality systems. We provide comprehensive analytical data to support its use in regulated environments. Our standard quality commitment includes high chemical purity and isotopic enrichment verified by advanced spectroscopic and chromatographic techniques. A detailed Certificate of Analysis (COA) specifying purity by HPLC, isotopic purity by MS, and identification data is supplied with each shipment.

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 material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant and inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity (MS)	≥98.0 atom % D
Chemical Purity (NMR)	Conforms
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.1%

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