Description

Loxoprofen Impurity 11/2-(4-((1-(Methoxycarbonyl)-2-Oxocyclopentyl)Methyl)Phenyl)Propanoic Acid is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity in the quality control and regulatory compliance of the non-steroidal anti-inflammatory drug (NSAID) Loxoprofen sodium. It is essential for analytical chemists and quality assurance professionals in the pharmaceutical industry who require reliable reference materials to ensure drug safety, efficacy, and adherence to stringent pharmacopeial guidelines such as ICH, USP, and EP.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Loxoprofen Impurity 11 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating stability-indicating HPLC, UPLC, or LC-MS methods for Loxoprofen sodium.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity profiles and ensure compliance with ICH Q3A(R2) and Q3B(R2) guidelines on impurities in new drug substances and products.
• Stability Studies: Employed as a marker to assess the degradation pathways and shelf-life of Loxoprofen formulations under various stress conditions.
• Regulatory Submissions: Supports the preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Research on Degradation Pathways: Facilitates studies into the formation mechanisms and toxicological significance of this specific impurity.

Basic Information

Product Name	Loxoprofen Impurity 11/2-(4-((1-(Methoxycarbonyl)-2-Oxocyclopentyl)Methyl)Phenyl)Propanoic Acid
CAS No.	1027957-36-3
Molecular Formula	C18H22O5
Molecular Weight	318.36 g/mol
Synonyms	Loxoprofen Impurity 11; 2-[4-[[1-(Methoxycarbonyl)-2-oxocyclopentyl]methyl]phenyl]propanoic acid; (RS)-2-(4-((1-(Methoxycarbonyl)-2-oxocyclopentyl)methyl)phenyl)propanoic acid; Loxoprofen Related Compound 11; Loxoprofen EP Impurity J; Loxoprofen Sodium Impurity 11; 2-(4-((1-(Methoxycarbonyl)-2-oxocyclopentyl)methyl)phenyl)propionic acid
EINECS	Contact for details

Quality Control

Our Loxoprofen Impurity 11 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using advanced techniques including HPLC, GC, NMR, and MS to confirm identity and purity. We provide full traceability and Certificates of Analysis (COA) that detail purity, impurity profiles, and results from all specified tests, ensuring compliance with pharmacopeial standards for reference materials. Our quality commitment supports your regulatory and research requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is moisture-sensitive (hygroscopic); ensure the container is sealed after each use to prevent absorption of water vapor.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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