Description

Olmesartan Medoxomil Impurity 4 is a designated impurity of the antihypertensive active pharmaceutical ingredient (API) Olmesartan Medoxomil. This compound is critical for pharmaceutical research and development, serving as a key reference standard in analytical method development and validation. It is primarily used by pharmaceutical manufacturers, quality control (QC) laboratories, and regulatory affairs departments to ensure the purity, safety, and efficacy of Olmesartan Medoxomil drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Olmesartan Medoxomil API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance: Employed in routine QC testing to ensure batch-to-batch consistency and compliance with pharmacopeial limits (e.g., ICH Q3A/B guidelines).
• Stability Studies: Used to track the formation and levels of this specific impurity during forced degradation and long-term stability studies of drug products.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity characterization and control.
• Research & Synthesis: Serves as an intermediate or marker in process chemistry research for the synthesis and purification of Olmesartan Medoxomil.

Basic Information

Product Name	Olmesartan Medoxomil Impurity 4
CAS No.	95579-71-8
Molecular Formula	C29H30N6O6
Molecular Weight	558.59 g/mol
Synonyms	Olmesartan Impurity 4; Olmesartan Medoxomil Related Compound 4; 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-(acetyloxy)-3-methoxy-2-butenyl ester; Benzenepropanoic acid, β-oxo-4-(1-hydroxy-1-methylethyl)-2-propyl-1-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1H-imidazol-5-yl ester, (3Z)-3-(acetyloxy)-2-methyl-2-butenoate; Olmesartan Medoxomil Ester Impurity
EINECS	Contact for details

Quality Control

Our Olmesartan Medoxomil Impurity 4 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency in line with ICH guidelines. Comprehensive characterization is performed using advanced techniques including HPLC, LC-MS, NMR, and IR spectroscopy. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with specified standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccant conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
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	≤ 0.5%

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