Description

Olmesartan Medoxomil Impurity V is a high-purity reference standard critical for analytical method development and validation in pharmaceutical quality control. This compound serves as a key impurity marker for ensuring the safety and efficacy of the antihypertensive drug Olmesartan Medoxomil. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for precise identification, quantification, and control of impurities in active pharmaceutical ingredients (APIs) and finished drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for calibrating analytical instruments and validating testing methods.
• Impurity Profiling & Identification: Essential for identifying and quantifying Olmesartan Medoxomil Impurity V in drug substance and drug product batches during stability studies and release testing.
• Method Development & Validation: A critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity analysis to meet ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Assurance & Control (QA/QC): Employed in routine QC laboratories to monitor impurity levels and ensure batch-to-batch consistency and compliance with regulatory specifications.
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Research & Development: Used in pharmaceutical R&D to study degradation pathways and the stability profile of Olmesartan Medoxomil.

Basic Information

Product Name	Olmesartan Medoxomil Impurity V
CAS No.	157356-74-6
Molecular Formula	C29H30N6O6
Molecular Weight	558.59 g/mol
Synonyms	Olmesartan Impurity V; 4-(1-Hydroxy-1-methylethyl)-2-propyl-1-({2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl}methyl)-1H-imidazole-5-carboxylic acid, 5-methyl-2-oxo-1,3-dioxol-4-yl)methyl ester; Benicar Impurity V; (5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl}-1H-imidazole-5-carboxylate; Olmesartan Medoxomil Related Compound V; UNII-8WZ9KJ5B1F
EINECS	Contact for details

Quality Control

Every batch of Olmesartan Medoxomil Impurity V is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC/UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
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%
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.