Description

Olmesartan Medoxomil Impurity I is a designated pharmaceutical impurity used as a critical reference standard in analytical chemistry. This compound is essential for ensuring the quality, safety, and efficacy of the antihypertensive drug Olmesartan Medoxomil by enabling precise identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and regulatory bodies for method development, validation, and routine batch analysis.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the identification and quantification of impurities in Olmesartan Medoxomil Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling in compliance with ICH guidelines.
• Quality Control & Batch Release Testing: A critical component in the quality control workflow to monitor impurity levels and ensure drug substance and product specifications are met.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) and audits by providing necessary data for impurity qualification as per ICH Q3A(R2) and Q3B(R2) requirements.
• Stability Studies: Employed to track the formation and growth of this specific impurity during forced degradation and long-term stability studies of Olmesartan Medoxomil.
• Research & Development: Used in R&D laboratories for studying degradation pathways and synthesis processes of Olmesartan Medoxomil.

Basic Information

Product Name	Olmesartan Medoxomil Impurity I
CAS No.	879562-26-2
Molecular Formula	C29H30N6O6
Molecular Weight	558.59 g/mol
Synonyms	Olmesartan Impurity I; 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; Olmesartan Medoxomil Related Compound I; (5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-({2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl}methyl)-1H-imidazole-5-carboxylate; Benicar Impurity I; CS-866 Impurity I
EINECS	Contact for details

Quality Control

Our Olmesartan Medoxomil Impurity I is manufactured and tested under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation, to ensure it meets the high standards required for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results for identity, assay, purity, and related substances. Our quality processes are designed to support compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

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

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