Description

Olmesartan Medoxomil Impurity 26 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Olmesartan Medoxomil by enabling precise identification and quantification of related substances. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies engaged in drug development, quality control, and compliance testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Olmesartan Medoxomil API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to meet ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release Testing: Used in routine QC laboratories to monitor impurity profiles and ensure batch-to-batch consistency of the antihypertensive drug.
• Stability Studies: Employed to track the formation of degradation products in Olmesartan Medoxomil under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over impurities.
• Research & Development: Supports impurity profiling, route scouting, and process chemistry research during API synthesis and scale-up.

Basic Information

Product Name	Olmesartan Medoxomil Impurity 26
CAS No.	1392475-91-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Olmesartan Medoxomil Related Compound 26; Olmesartan Impurity 26; 4-(1-Hydroxy-1-methylethyl)-2-propyl-1-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1H-imidazole-5-carboxylic acid, 4-(chloromethyl)-2-oxo-2H-1,3-benzodioxol-5-yl ester; Benzoic acid, 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1H-imidazol-5-yl ester, 4-(chloromethyl)-1,3-benzodioxol-2-one-5-yl ester; Olmesartan Medoxomil Chloromethyl Ester Impurity
EINECS	Contact for details

Quality Control

Our Olmesartan Medoxomil Impurity 26 is manufactured under strict quality management 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 with each shipment, detailing batch-specific results, analytical methods, and traceability. We support compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled room temperature, typically between 15-25°C (59-77°F). The product 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 (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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