Description

Loxoprofen Impurity 13 is a designated impurity standard used in the analytical profiling and quality control of the non-steroidal anti-inflammatory drug (NSAID) Loxoprofen. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development, production, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Loxoprofen Impurity 13 in API and finished dosage forms.
• Method Development and Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, for Loxoprofen.
• Quality Control & Assurance (QC/QA): A critical component in routine batch release testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Used in synthetic chemistry research to understand degradation pathways and to improve purification processes for Loxoprofen.

Basic Information

Product Name	Loxoprofen Impurity 13
CAS No.	308279-38-1
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 13 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 (USP, EP, JP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatograms, and traceability information.

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 light-sensitive (store away from light); therefore, containers must be kept tightly sealed in a desiccated environment to prevent degradation and absorption of moisture.

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)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.