Description

Loxoprofen Impurity 14 is a designated reference standard used in the analytical profiling and quality control of the non-steroidal anti-inflammatory drug (NSAID) Loxoprofen Sodium. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and as a critical component in impurity identification studies for Loxoprofen drug substances and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quantitative and qualitative analysis of Loxoprofen Sodium.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, or GC methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing to monitor and control impurity levels in active pharmaceutical ingredients (APIs).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs).
• Stability Studies: Employed to identify and quantify degradation products formed under various stress conditions.
• Pharmacopoeial Testing: Used in testing to meet the specifications of pharmacopoeias such as USP, EP, or JP.

Basic Information

Product Name	Loxoprofen Impurity 14
CAS No.	81762-82-5
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
EINECS	Contact for details

Quality Control

Every batch of Loxoprofen Impurity 14 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS, IR) techniques to ensure compliance with pharmacopoeial and in-house specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 under inert conditions or in a desiccator to maintain stability and purity.

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 unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%

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