Description

Loxoprofen Impurity 40 is a high-purity chemical reference standard used in the analytical profiling and quality control of the non-steroidal anti-inflammatory drug (NSAID) Loxoprofen. This impurity is critical for pharmaceutical manufacturers and analytical laboratories to ensure drug safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is an essential component for method development, validation, and stability studies within the pharmaceutical research and development sector.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Loxoprofen-related impurities in Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating chromatographic methods (HPLC, UPLC) to separate and analyze impurities in Loxoprofen sodium.
• Stability Studies & Forced Degradation: Used to monitor the formation of degradation products under various stress conditions (heat, light, humidity, acid/base) to establish product shelf-life.
• Quality Control & Batch Release Testing: Essential for routine QC testing to ensure Loxoprofen batches meet stringent pharmacopeial (e.g., USP, EP, JP) specifications for impurity profiles.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing characterized impurity standards for safety and quality documentation (ICH Q3B).
• Research on Drug Metabolism & Impurity Pathways: Aids in research to understand the degradation pathways and metabolic byproducts of Loxoprofen.

Basic Information

Product Name	Loxoprofen Impurity 40
CAS No.	1152440-23-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Loxoprofen Related Compound 40; Loxoprofen EP Impurity J; Loxoprofen Sodium Impurity 40; Loxoprofen Degradant; Loxoprofen Process Impurity; 2-[4-[(2-Oxocyclopentyl)methyl]phenyl]propanoic acid (related isomer); Loxoprofen Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Loxoprofen Impurity 40 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC and mass spectrometry to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and other critical quality attributes.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under inert atmosphere if specified.

Specification

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

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