Description

Loxoprofen Impurity 35 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 active pharmaceutical ingredient (API) Loxoprofen Sodium. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing of Loxoprofen-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Loxoprofen Sodium API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurities during the drug manufacturing process.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and calibration standard in routine quality control testing to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity profiles and characterization data for drug master files (DMFs).
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (thermal, photolytic, hydrolytic) as per ICH stability protocols.
• Research & Development: Used in pharmaceutical R&D to study the degradation pathways, metabolism, and toxicological profile of Loxoprofen.

Basic Information

Product Name	Loxoprofen Impurity 35
CAS No.	1823911-62-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Loxoprofen Related Compound 35; Loxoprofen Sodium Impurity 35; Loxoprofen EP Impurity G; Loxoprofen USP Impurity; 2-[4-[(2-Oxocyclopentyl)methyl]phenyl]propanoic acid (related compound); Loxoprofen Degradant; Loxoprofen Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Loxoprofen Impurity 35 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and strength testing to ensure compliance with relevant pharmacopeial standards (e.g., USP, EP, ICH Q3A/B). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC purity assay, related substance analysis, and spectroscopic identification (IR, NMR, MS).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. The material should be kept in a cool, dry, and well-ventilated area. Handle and store under an inert atmosphere if specified.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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