Description

Olmesartan Medoxomil Impurity 28 is a high-purity reference 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 safety, efficacy, and regulatory compliance by accurately identifying and quantifying process-related impurities. It is an essential material for research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Olmesartan Medoxomil API.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) for pharmaceutical quality control.
• Used in stability studies and forced degradation studies to monitor impurity profiles over time.
• Essential for regulatory compliance and filing (e.g., ICH guidelines, FDA, EMA submissions) requiring impurity characterization.
• Supports research and development of Olmesartan Medoxomil and related pharmaceutical compounds.
• Utilized by contract research organizations (CROs) and quality assurance laboratories for batch release testing.

Basic Information

Product Name	Olmesartan Medoxomil Impurity 28
CAS No.	1127249-17-5
Molecular Formula	C29H30N6O6
Molecular Weight	558.59 g/mol
Synonyms	Olmesartan Medoxomil Related Compound 28; 5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-({4-[2-(2H-1,2,3,4-tetrazol-5-yl)phenyl]phenyl}methyl)-1H-imidazole-5-carboxylate; Olmesartan Medoxomil Impurity O; Olmesartan Medoxomil EP Impurity G; Olmesartan Impurity 28; Benzimidazole impurity of Olmesartan Medoxomil; UNII-7K3P6S90U4
EINECS	Contact for details

Quality Control

Every batch of Olmesartan Medoxomil Impurity 28 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure the highest standards of identity, purity, and stability, compliant with ICH Q3A/B guidelines. A comprehensive Certificate of Analysis (COA) detailing purity, chromatographic data, and spectroscopic confirmation is provided with each shipment to support your regulatory and quality assurance needs.

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 corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.