Description

Olmesartan Medoxomil Impurity 10 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 by accurately identifying and quantifying related substances. It is primarily utilized by professionals in pharmaceutical R&D, quality assurance (QA), and quality control (QC) departments involved in the development and production of Olmesartan Medoxomil drug substances and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Olmesartan Medoxomil Impurity 10 in API and finished drug products.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and LC-MS, for impurity profiling.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines and pharmacopeial specifications (USP, EP).
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (e.g., heat, humidity, light) to establish product shelf-life.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the API's impurity profile.
• Research and Development: Aids in synthetic route optimization and process chemistry by helping to identify and control the formation of this impurity during API manufacturing.

Basic Information

Product Name	Olmesartan Medoxomil Impurity 10
CAS No.	2101308-73-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Olmesartan Medoxomil Related Compound 10; Olmesartan Impurity 10; 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 impurity; UNII-9QZ5Y5W5F8; Benzimidazole derivative impurity of Olmesartan Medoxomil
EINECS	Contact for details

Quality Control

Our Olmesartan Medoxomil Impurity 10 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency. We provide comprehensive Certificates of Analysis (COA) that include data from orthogonal techniques such as HPLC, NMR, and MS. Our standards are suitable for use in compliance with current Good Manufacturing Practice (cGMP) and ICH Q3A/B guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity. Avoid repeated or prolonged exposure to the atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum consistent with 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.