Description

Loxoprofen Impurity 11 is a specified impurity and degradation product of the non-steroidal anti-inflammatory drug (NSAID) Loxoprofen. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, stability studies, and quality control. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug purity, safety, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Loxoprofen Sodium 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.
• Stability and Forced Degradation Studies: Employed to understand the degradation pathways of Loxoprofen and to establish appropriate storage conditions and shelf life.
• Quality Control & Batch Release Testing: A critical component in the quality control laboratory for routine analysis to ensure API and drug product batches meet ICH Q3A/B guidelines.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity characterization, qualification, and control strategies.
• Research on Drug Metabolism and Pharmacokinetics (DMPK): Can be utilized in metabolic studies to investigate the biotransformation pathways of Loxoprofen.

Basic Information

Item	Details
Product Name	Loxoprofen Impurity 11
CAS No.	81762-92-7
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]propanoic acid
EINECS	Contact for details

Quality Control

Our Loxoprofen Impurity 11 is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH guidelines. Certificates are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. For long-term storage, consider storing at 2-8°C. Handle the material in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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