Description

Loxoprofen Impurity 18 is a specified impurity and degradation product of the non-steroidal anti-inflammatory drug (NSAID) Loxoprofen. This compound is of critical importance for pharmaceutical manufacturers and analytical laboratories engaged in the development, quality control, and regulatory compliance of Loxoprofen-based drug products. It serves as a vital reference standard for ensuring drug purity, safety, and efficacy. Primary users include R&D scientists, quality assurance professionals, and suppliers within the global pharmaceutical and fine chemical industries.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Loxoprofen Impurity 18 in active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development and Validation: Essential for developing and validating analytical methods, such as HPLC and UPLC, to monitor impurities in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance: Employed in routine QC testing to establish impurity profiles, set specification limits, and ensure batch-to-batch consistency of Loxoprofen sodium.
• Stability Studies: A key analyte in forced degradation and long-term stability studies to understand the degradation pathways of Loxoprofen and establish appropriate shelf-life.
• Regulatory Submissions: Critical for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate comprehensive impurity control and the safety of the drug substance.
• Research on Degradation Pathways: Used in academic and industrial research to study the metabolism and chemical degradation behavior of Loxoprofen.

Basic Information

Item	Detail
Product Name	Loxoprofen Impurity 18
CAS No.	99807-54-2
Molecular Formula	C15H18O3
Molecular Weight	246.30 g/mol
Synonyms	2-[4-[(2-Oxocyclopentyl)methyl]phenyl]propanoic Acid; Loxoprofen Related Compound; Loxoprofen EP Impurity; Loxoprofen USP Impurity; Loxoprofen Degradation Product; (±)-2-[4-[(2-Oxocyclopentyl)methyl]phenyl]propionic Acid; Loxoprofen Ketone Impurity
EINECS	Contact for details

Quality Control

Every batch of Loxoprofen Impurity 18 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided with each shipment to support your quality and regulatory requirements.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

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)	Single unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residue on Ignition	≤ 0.5%

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