Description

Olmesartan Medoxomil Impurity 7 is a high-purity reference standard critical for analytical method development and quality control in pharmaceutical manufacturing. This compound is essential for ensuring the safety and efficacy of Olmesartan Medoxomil, an important antihypertensive API, by enabling the accurate identification and quantification of related substances. It is primarily required by pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and contract research organizations (CROs) involved in the production and regulatory compliance of generic and innovator drug products.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for calibrating analytical instruments and validating testing methods.
• Method Development and Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for impurity profiling of Olmesartan Medoxomil.
• Quality Control and Batch Release: Employed in routine QC testing to monitor and control the level of this specific impurity in active pharmaceutical ingredient (API) and finished drug product batches.
• Stability Studies: A key marker for assessing the degradation pathways and shelf-life of Olmesartan Medoxomil under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and ICH guidelines.
• Research and Development: Used in synthetic chemistry research to study impurity formation mechanisms and to develop purification processes.

Basic Information

Product Name	Olmesartan Medoxomil Impurity 7
CAS No.	2101308-74-9
Molecular Formula	C29H30N6O6
Molecular Weight	558.59 g/mol
Synonyms	Olmesartan Impurity 7; Olmesartan Medoxomil Related Compound 7; 5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-({4-[2-(2H-1,2,3,4-tetrazol-5-yl)phenyl]phenyl}methyl)-1H-imidazole-5-carboxylate; UNII-7F4I8X3Q4R; Benzimidazole Impurity of Olmesartan; Olmesartan Medoxomil Benzimidazole Analog; Olmesartan EP Impurity G; Olmesartan Medoxomil Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Olmesartan Medoxomil Impurity 7 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards (USP, EP, ICH). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request for evaluation.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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