Description

Trityl Olmesartan Medoxomil Impurity Ii is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Olmesartan Medoxomil, an important angiotensin II receptor blocker (ARB) antihypertensive medication. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification during analytical testing. It is an essential material for analytical chemists, quality assurance professionals, and researchers in pharmaceutical R&D and manufacturing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of process-related impurities in Olmesartan Medoxomil Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Method Development and Validation: Crucial for developing, optimizing, and validating stability-indicating analytical methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure drug substance and drug product purity meets stringent pharmacopeial standards (e.g., USP, EP, ICH guidelines).
• Stability Studies: Employed to track the formation and levels of this specific impurity under various stress conditions (heat, light, humidity) as per ICH Q1A(R2) requirements.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing necessary impurity characterization data.
• Research & Development: Aids in process chemistry research to understand and minimize the formation of this impurity during API synthesis.

Basic Information

Product Name	Trityl Olmesartan Medoxomil Impurity Ii
CAS No.	1040405-56-8
Molecular Formula	C41H40N6O7
Molecular Weight	728.80 g/mol
Synonyms	4-(1-Hydroxy-1-methylethyl)-2-propyl-1-({2'-(1-trityl-1H-tetrazol-5-yl)biphenyl-4-yl}methyl)-1H-imidazole-5-carboxylic acid 5-methyl-2-oxo-1,3-dioxol-4-yl)methyl ester; Olmesartan Medoxomil Trityl Impurity II; Olmesartan Medoxomil Related Compound Ii; UNII-2B4Q6Z6VQ2; Benzoic acid, 4-((1-hydroxy-1-methylethyl)-2-propyl-1-((2'-(1-trityl-1H-tetrazol-5-yl)(1,1'-biphenyl)-4-yl)methyl)-1H-imidazol-5-yl)-, (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl ester
EINECS	Contact for details

Quality Control

Every batch of Trityl Olmesartan Medoxomil Impurity Ii is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, NMR, and MS to ensure compliance with pharmacopeial and ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

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.

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)	Single unknown impurity ≤ 1.0% 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.