Description

Olmesartan Medoxomil Impurity G is a designated impurity standard used in the analytical profiling and quality control of the antihypertensive active pharmaceutical ingredient (API), Olmesartan Medoxomil. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Primary use as a reference standard for the identification and quantification of Impurity G in Olmesartan Medoxomil API and finished dosage forms.
• Essential for method development and validation of HPLC, UPLC, and other chromatographic analytical procedures.
• Critical component in stability-indicating studies to monitor degradation pathways and establish shelf-life for pharmaceutical products.
• Used in quality control (QC) and quality assurance (QA) laboratories to ensure batch-to-batch consistency and compliance with pharmacopeial standards (e.g., USP, EP).
• Supports regulatory submissions (e.g., for FDA, EMA) by providing necessary impurity data for drug master files (DMFs).
• Valuable for academic and contract research organizations (CROs) conducting pharmaceutical research on sartan-class drugs.

Basic Information

Product Name	Olmesartan Medoxomil Impurity G
CAS No.	761404-82-4
Molecular Formula	C29H30N6O6
Molecular Weight	558.59 g/mol
Synonyms	4-(1-Hydroxy-1-methylethyl)-2-propyl-1-({2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl}methyl)-1H-imidazole-5-carboxylic acid, 1-[[(2,3-Dihydroxy-2-buten-1-yl)oxy]carbonyl]oxyethyl ester; Olmesartan Medoxomil Related Compound G; Benzenepropanoic acid, β-hydroxy-α-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-4-(1-hydroxy-1-methylethyl)-2-propyl-1H-imidazole-5-, 1-[[(2,3-dihydroxy-2-buten-1-yl)oxy]carbonyl]oxyethyl ester; Impurity G of Olmesartan Medoxomil.
EINECS	Contact for details

Quality Control

Our Olmesartan Medoxomil Impurity G is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing to ensure high purity and accurate identification, aligning with the requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, chromatographic data, and structural confirmation. We support compliance with ICH Q3A/B guidelines and relevant pharmacopeial monographs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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