Description

Olmesartan Impurity 21 is a designated pharmaceutical reference standard used in the quality control and analytical development of the antihypertensive drug Olmesartan medoxomil. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Olmesartan medoxomil Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurities during the drug manufacturing process.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure drug substance and product meet stringent pharmacopeial (e.g., USP, EP) specifications for impurity limits.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light) to establish product shelf life.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary data on impurity characterization and control strategies for health authorities like the FDA and EMA.
• Research & Development (R&D): Facilitates research into the degradation pathways and metabolism of Olmesartan medoxomil.

Basic Information

Product Name	Olmesartan Impurity 21
CAS No.	885216-74-0
Molecular Formula	C29H30N6O6
Molecular Weight	558.59 g/mol
Synonyms	Olmesartan Medoxomil Impurity 21; 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-(Morpholinocarbonyl)benzyl ester; Benzenepropanoic acid, β-oxo-4-(morpholinylcarbonyl)-, 1-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-2-propyl-4-(1-hydroxy-1-methylethyl)-1H-imidazol-5-yl ester; Olmesartan Ester Impurity
EINECS	Contact for details

Quality Control

Our Olmesartan Impurity 21 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure high purity and batch-to-batch consistency suitable for use as a reference standard. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results for identity, purity (by HPLC), and related substances. While not officially certified, our material is characterized against available pharmacopeial data and is ideal for in-house quality control applications.

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 product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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