Description

Loxoprofen Impurity 15 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the non-steroidal anti-inflammatory drug (NSAID) Loxoprofen sodium. It serves as a key marker for identification and quantification during pharmaceutical development and quality control processes. This impurity standard is essential for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing.

Application

• Primary use as a certified reference standard for the analysis of Loxoprofen sodium drug substance and finished products.
• Method development and validation for impurity profiling in pharmaceutical quality control (QC) laboratories.
• Calibration of analytical instruments such as HPLC, UPLC, and LC-MS systems for precise quantification.
• Stability studies and forced degradation studies to understand the degradation pathways of Loxoprofen.
• Pharmacopoeial testing to meet the requirements of standards like USP, EP, and JP.
• Research and development of impurity synthesis pathways and control strategies.
• Supporting regulatory filings (e.g., ANDA, NDA) by providing characterized impurity data.

Basic Information

Product Name	Loxoprofen Impurity 15
CAS No.	1091621-62-3
Molecular Formula	C15H18O3
Molecular Weight	246.30 g/mol
Synonyms	Loxoprofen Related Compound 15; Loxoprofen EP Impurity C; Loxoprofen Sodium Impurity 15; 2-[4-[(2-Oxocyclopentyl)methyl]phenyl]propanoic Acid; (RS)-2-[4-[(2-Oxocyclopentyl)methyl]phenyl]propanoic Acid
EINECS	Contact for details

Quality Control

Every batch of Loxoprofen Impurity 15 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and traceability. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B guidelines and pharmacopoeial standards for pharmaceutical impurities.

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 in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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