Description

Olmesartan Impurity 58 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antihypertensive 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 drug substance and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity levels in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control (QC) Testing: Employed in routine QC laboratories to ensure batch-to-batch consistency and that impurity levels remain within specified safety thresholds.
• Stability Studies: Used to track the formation of degradation products in Olmesartan formulations under various stress conditions (e.g., heat, humidity, light).
• Regulatory Submissions: Essential for preparing documentation for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies to agencies like the US FDA and EMA.
• Research & Development: Utilized in pharmaceutical R&D to study the degradation pathways and chemical behavior of Olmesartan Medoxomil.

Basic Information

Product Name	Olmesartan Impurity 58
CAS No.	2190488-06-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Olmesartan Related Compound 58; Olmesartan Medoxomil Impurity 58; 4-(1-Hydroxy-1-methylethyl)-2-propyl-1-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1H-imidazole-5-carboxylic acid (Olmesartan Impurity); UNII-Contact for details; (5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]imidazole-5-carboxylate impurity; Benicar Impurity; BPB Impurity
EINECS	Contact for details

Quality Control

Our Olmesartan Impurity 58 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques like NMR, MS, and HPLC to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, assay, and impurity profile, supporting compliance with ICH and pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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