Description

Trityl Olmesartan Medoxomil Impurity Iii is a high-purity reference standard critical for the analytical profiling and quality control of the active pharmaceutical ingredient, Olmesartan Medoxomil. This compound serves as a key impurity marker, enabling pharmaceutical manufacturers to ensure product safety, efficacy, and compliance with stringent regulatory guidelines. It is essential for research and development, method validation, and stability studies within the pharmaceutical and analytical chemistry sectors.

Application

• Pharmaceutical Impurity Reference Standard: Primary use as a certified reference material for the identification and quantification of process-related impurities in Olmesartan Medoxomil API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Stability Indicating Studies: Used to monitor impurity profiles and assess the stability of Olmesartan Medoxomil under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity data to agencies like the US FDA, EMA, and PMDA.
• Pharmaceutical R&D: Aids in process chemistry research to understand and minimize impurity formation during API synthesis.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability standard and for routine batch release testing to ensure product specifications are met.

Basic Information

Product Name	Trityl Olmesartan Medoxomil Impurity Iii
CAS No.	1227626-51-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Olmesartan Medoxomil Trityl Impurity III; Olmesartan Medoxomil Related Compound III; 4-(1-Hydroxy-1-methylethyl)-2-propyl-1-[[2'-(1-trityl-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; Benicar Impurity III (Trityl); (5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[[2'-(1-trityl-1H-tetrazol-5-yl)biphenyl-4-yl]methyl]imidazole-5-carboxylate
EINECS	Contact for details

Quality Control

Our Trityl Olmesartan Medoxomil Impurity Iii is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results for purity, impurities, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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 solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.