Description

Olmesartan Impurity 9 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Olmesartan Medoxomil. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Olmesartan Medoxomil API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity levels.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in pharmaceutical QC laboratories to ensure API purity meets pharmacopeial standards (e.g., USP, EP).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing data on impurity characterization and control strategies.
• Stability Studies: Employed in forced degradation and long-term stability studies of Olmesartan to understand impurity formation pathways.
• Research & Development: Used in pharmaceutical R&D for studying the synthesis, degradation chemistry, and metabolic pathways of Olmesartan analogs.

Basic Information

Product Name	Olmesartan Impurity 9
CAS No.	849206-42-4
Molecular Formula	C29H30N6O6
Molecular Weight	558.59 g/mol
Synonyms	Olmesartan Medoxomil Impurity 9; 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; 1H-Imidazole-5-carboxylic acid, 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[[2'-(2H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-, (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl ester; Olmesartan Ester Impurity; Benzimidazole Impurity of Olmesartan
EINECS	Contact for details

Quality Control

Every batch of Olmesartan Impurity 9 is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity, purity, and impurity testing to ensure compliance with pharmaceutical reference standard requirements. Comprehensive characterization is performed using advanced techniques including HPLC, LC-MS, and NMR. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming batch-specific data.

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. The material is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown 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.