Description

Loxoprofen Impurity 34 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 pharmaceutical manufacturers and analytical laboratories to ensure drug purity, safety, and regulatory compliance. It serves as a key reference material for method development, validation, and routine testing in the production of Loxoprofen sodium.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Loxoprofen active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Loxoprofen meets pharmacopeial specifications (e.g., ICH Q3A/B, USP, EP) for impurity limits.
• Stability Studies: Employed to track the formation and levels of this specific impurity under various stress conditions (heat, light, humidity) as part of drug stability programs.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and optimize manufacturing processes to minimize impurity formation.

Basic Information

Product Name	Loxoprofen Impurity 34
CAS No.	1182733-62-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Loxoprofen Related Compound 34; Loxoprofen EP Impurity D; Loxoprofen USP Impurity; Loxoprofen Degradation Product; 2-[4-[(2-Oxocyclopentyl)methyl]phenyl]propanoic Acid (Related Compound); Loxoprofen Sodium Impurity 34
EINECS	Contact for details

Quality Control

Every batch of Loxoprofen Impurity 34 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Assay	≥ 98.0% (on dried basis)
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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