Description

Loxoprofen Impurity 31 is a designated impurity standard of the non-steroidal anti-inflammatory drug (NSAID) Loxoprofen. This high-purity reference material is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality assurance (QA) departments, and contract research organizations (CROs) to ensure drug purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Loxoprofen Impurity 31 in active pharmaceutical ingredient (API) and finished drug product analysis.
• Method Development and Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC, UPLC, and LC-MS, in compliance with ICH guidelines.
• Quality Control and Batch Release: Serves as a system suitability standard and for preparing calibration curves to monitor impurity levels during Loxoprofen production.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Pharmacopoeial Testing: Supports testing to meet the impurity specifications outlined in pharmacopoeias like USP, EP, and JP.

Basic Information

Product Name	Loxoprofen Impurity 31
CAS No.	37062-67-2
Molecular Formula	C15H18O3S
Molecular Weight	278.37 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 31 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 pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided and available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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