Description

Irbesartan n-β-D-2,3,4-Tri-o-Acetyl-Glucuronide Methyl Ester is a key synthetic intermediate in the production of irbesartan metabolites and related pharmaceutical compounds. This high-purity intermediate is critical for research and development in analytical chemistry, pharmacokinetic studies, and the synthesis of reference standards. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and manufacturers of active pharmaceutical ingredients (APIs) and fine chemicals.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the quantification and qualification of irbesartan metabolites in biological matrices during drug metabolism and pharmacokinetics (DMPK) studies.
• Metabolite Synthesis: Acts as a crucial precursor in the synthetic pathway for producing glucuronidated metabolites of the antihypertensive drug Irbesartan for toxicological and clinical research.
• Analytical Method Development: Used to develop and validate high-performance liquid chromatography (HPLC) and liquid chromatography-mass spectrometry (LC-MS/MS) methods in bioanalytical laboratories.
• Process Chemistry & API Development: Employed in route scouting and process optimization for the manufacture of irbesartan and its derivatives, ensuring supply chain robustness for advanced intermediates.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing well-characterized material for impurity profiling and stability studies.

Basic Information

Product Name	Irbesartan n-β-D-2,3,4-Tri-o-Acetyl-Glucuronide Methyl Ester
CAS No.	224170-69-8
Molecular Formula	C36H42N6O12
Molecular Weight	726.75 g/mol
Synonyms	Irbesartan Glucuronide Methyl Ester Triacetate; Methyl (2S,3S,4S,5R,6S)-3,4,5-triacetoxy-6-((4-((2'-(2H-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)-2-butyl-1,3-diazaspiro[4.4]non-1-en-3-yl)oxy)tetrahydro-2H-pyran-2-carboxylate; Irbesartan Triacetyl Glucuronide Methyl Ester; Irbesartan Metabolite Intermediate; BMS 186295 Intermediate; SR 47436 Glucuronide Derivative
EINECS	Contact for details

Quality Control

Our Irbesartan n-β-D-2,3,4-Tri-o-Acetyl-Glucuronide Methyl Ester is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via NMR and mass spectrometry, to ensure it meets the stringent requirements for pharmaceutical research and development. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
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.