Description

Olmesartan Impurity 1 is a designated pharmaceutical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the antihypertensive drug Olmesartan medoxomil by serving as a key marker for impurity profiling and control. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies engaged in drug development, quality assurance, and compliance testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Olmesartan medoxomil active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical component in developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity detection.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring compliance with pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Used to track the formation of degradation products in Olmesartan formulations 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 comprehensive impurity control.
• Research and Development: Facilitates studies on the degradation pathways, metabolism, and synthesis of Olmesartan and related compounds.

Basic Information

Item	Details
Product Name	Olmesartan Impurity 1
CAS No.	1219207-91-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Olmesartan Related Compound 1; Olmesartan Medoxomil Impurity 1; 4-(1-Hydroxy-1-methylethyl)-2-propyl-1-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1H-imidazole-5-carboxylic acid; Benzenepropanoic acid, β-oxo-α-[[2-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-, 1-methylethyl ester (related); Olmesartan Acid Impurity; Olmesartan EP Impurity A; Olmesartan USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Olmesartan Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

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 (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0%; Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%

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