Description

Olmesartan Medoxomil Impurity 2 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antihypertensive active pharmaceutical ingredient (API) Olmesartan Medoxomil. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Olmesartan Medoxomil API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation of this impurity under various stress conditions (e.g., heat, humidity, light) to establish product shelf-life.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Pharmacopoeial Testing: Used as a system suitability standard in testing to comply with pharmacopoeial monographs (USP, EP, JP).
• Research & Development: Supports synthetic chemistry research aimed at understanding degradation pathways and improving synthetic processes for Olmesartan Medoxomil.

Basic Information

Product Name	Olmesartan Medoxomil Impurity 2
CAS No.	1878117-43-1
Molecular Formula	C29H30N6O6
Molecular Weight	558.59 g/mol
Synonyms	Olmesartan Medoxomil Related Compound 2; Olmesartan Impurity 2; 4-(1-Hydroxy-1-methylethyl)-2-propyl-1-({2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl}methyl)-1H-imidazole-5-carboxylic acid (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl ester; UNII-9FQ2K91I4F; Benzoic acid, 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]imidazol-5-yl ester, cyclic carbonate (1:1)
EINECS	Contact for details

Quality Control

Every batch of Olmesartan Medoxomil Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques (HPLC, LC-MS, NMR) to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatograms, and traceability information.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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