Description

Olmesartan Intermediate Impurity Ii is a high-purity chemical reference standard used in the analytical profiling and quality control of pharmaceutical active ingredients. This compound is critical for ensuring the safety and efficacy of Olmesartan medoxomil, a widely prescribed antihypertensive drug, by enabling the accurate identification and quantification of process-related impurities. It is an essential material for analytical chemists and quality assurance professionals in the pharmaceutical industry, particularly those involved in API manufacturing, regulatory compliance, and method development.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Olmesartan medoxomil drug substance and finished dosage forms.
• Analytical Method Development & Validation: A critical component in developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Batch Release: Used in routine QC testing of Active Pharmaceutical Ingredients (APIs) to ensure batches meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurities.
• Stability Studies: Employed to monitor the formation of degradation products in Olmesartan formulations under various stress conditions (e.g., heat, humidity, light).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Research & Development: Supports synthetic route optimization and process chemistry studies by tracking the formation and purge of this specific intermediate impurity.

Basic Information

Product Name	Olmesartan Intermediate Impurity Ii
CAS No.	144690-07-3
Molecular Formula	C29H30N6O6
Molecular Weight	558.59 g/mol
Synonyms	Olmesartan Impurity I; Olmesartan Related Compound 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 Trityl Ester; 1-[[2'-(1-Trityl-1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-2-propyl-4-(2-hydroxypropan-2-yl)-1H-imidazole-5-carboxylic Acid Trityl Ester; Olmesartan Medoxomil Intermediate Impurity; Olmesartan Trityl Ester Impurity; BIBR-277 Trityl Ester
EINECS	Contact for details

Quality Control

Every batch of Olmesartan Intermediate Impurity Ii is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with ICH Q3A, Q3B, and relevant pharmacopeial 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). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption, which could affect stability and purity. For long-term storage, consider desiccants or inert atmosphere packaging.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual 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.