Description

Irbesartan-D7 is a deuterium-labeled analog of the antihypertensive drug Irbesartan, specifically designed for use as an internal standard in quantitative analytical methods. This high-purity stable isotope-labeled compound is essential for ensuring accuracy and reliability in mass spectrometry-based analyses, such as LC-MS/MS. It is primarily utilized by pharmaceutical research and development laboratories, clinical research organizations, and quality control departments for pharmacokinetic studies, bioanalytical method development, and drug metabolism research.

Application

• Internal Standard for Bioanalysis: Serves as a critical internal standard in the quantification of Irbesartan in biological matrices (plasma, serum, urine) using LC-MS/MS, correcting for variability in sample preparation and instrument analysis.
• Pharmacokinetic and Metabolism Studies: Enables precise tracking and measurement of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Method Development and Validation: Used as a reference material to develop, optimize, and validate robust and compliant bioanalytical methods according to FDA and ICH guidelines.
• Drug Impurity Profiling: Assists in the identification and quantification of metabolites or related substances in drug substance and product testing.
• Clinical Research: Supports therapeutic drug monitoring and clinical trial sample analysis to ensure data integrity.
• Quality Control and Assurance: Provides a definitive reference for in-house quality control procedures within pharmaceutical manufacturing.

Basic Information

Product Name	Irbesartan-D7
CAS No.	1329496-43-6
Molecular Formula	C25H21D7N6O
Molecular Weight	436.56 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-D7; Irbesartan (phenyl-D7); 2-n-Butyl-3-[(2'-(1H-tetrazol-5-yl)biphenyl-4-yl)methyl]-1,3-diazaspiro[4.4]non-1-en-4-one-D7; BMS-186295-D7; SR 47436-D7; Avapro-D7 (labeled analog); Deuterated Irbesartan
EINECS	Contact for details

Quality Control

Every batch of Irbesartan-D7 is manufactured and tested under strict quality management systems. We provide comprehensive analytical data to support its use in regulated environments. Certificates of Analysis (COA) are supplied with each shipment, detailing key parameters such as isotopic purity, chemical purity (by HPLC), and confirmation of structure. Our quality commitment ensures consistency and reliability for your critical research applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); the original container must be kept tightly sealed in a dry environment to maintain stability and purity. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity	≥ 98.0 atom % D
Chemical Purity	≥ 95.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.5%

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