Description

Loxoprofen Impurity 32 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 non-steroidal anti-inflammatory drug (NSAID) Loxoprofen sodium. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Loxoprofen sodium active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods in quality control (QC) laboratories.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA, PMDA) to demonstrate comprehensive impurity control and adherence to ICH Q3A/B guidelines.
• Stability Studies: Employed in forced degradation and long-term stability studies of Loxoprofen to monitor impurity formation pathways and establish shelf-life specifications.
• Chemical Research & Synthesis: Acts as a key intermediate or marker for research chemists working on the synthesis, metabolism, or degradation pathways of Loxoprofen and related compounds.
• Quality Assurance/Quality Control (QA/QC): Used for routine batch release testing to ensure the impurity profile of Loxoprofen API meets the required pharmacopeial or in-house specifications.

Basic Information

Product Name	Loxoprofen Impurity 32
CAS No.	2304892-80-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Loxoprofen Related Compound 32; Loxoprofen Sodium Impurity 32; Loxoprofen EP Impurity G; Loxoprofen USP Impurity; 2-[4-[(2-Oxocyclopentyl)methyl]phenyl]propanoic Acid Impurity; Loxoprofen Degradant; Loxoprofen Process Impurity
EINECS	Contact for details

Quality Control

Our Loxoprofen Impurity 32 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via NMR and MS, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

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. The product is intended for laboratory use by qualified professionals.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Meets requirement
Residual Solvents (GC)	Meets ICH limits
Water Content (KF)	≤ 5.0%

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