Description

Olmesartan Lactone Impurity is a key chemical reference standard used in the pharmaceutical development and quality control of Olmesartan medoxomil, an important angiotensin II receptor blocker (ARB) antihypertensive medication. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify the lactone impurity in Olmesartan medoxomil active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing, validating, and verifying High-Performance Liquid Chromatography (HPLC) and other chromatographic methods.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to monitor the formation of this specific degradation product under various stress conditions.
• Quality Control (QC) Testing: Essential for routine batch release testing in API and drug product manufacturing to ensure compliance with stringent pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive understanding and control of product-related impurities.
• Research and Development: Utilized in synthetic chemistry research to study the degradation pathways of Olmesartan and to develop improved synthetic processes with lower impurity levels.

Basic Information

Product Name	Olmesartan Lactone Impurity
CAS No.	849206-43-5
Molecular Formula	C29H30N6O3
Molecular Weight	510.59 g/mol
Synonyms	Olmesartan Medoxomil Lactone; Olmesartan Impurity L; Olmesartan Related Compound L; 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 lactone; (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)-1H-imidazole-5-carboxylate lactone; Benicar Lactone Impurity; RNH-6270 Lactone.
EINECS	Contact for details

Quality Control

Our Olmesartan Lactone Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is supplied with each lot, detailing purity, assay, and impurity profile. Our quality commitment aligns with ICH Q3A, Q3B, and relevant pharmacopeial (USP/EP) guidelines for impurities in new drug substances and products.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown 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.