Description

Loxoprofen Ring-Opening Impurity CAS NO 1091621-61-2 is a critical reference standard used in the pharmaceutical development and quality control of the non-steroidal anti-inflammatory drug (NSAID) Loxoprofen. This impurity compound is essential for ensuring the purity, safety, and efficacy of the final drug product by enabling accurate identification and quantification during analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in API synthesis, method validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for HPLC, LC-MS, and other chromatographic methods in drug substance and drug product analysis.
• Method Development and Validation: Critical for developing and validating stability-indicating analytical methods for Loxoprofen sodium and related formulations.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides necessary data for impurity profiling in regulatory filings (e.g., ANDA, NDA) to agencies like the US FDA, EMA, and PMDA.
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity).
• Research & Development (R&D): Facilitates process chemistry research to understand and minimize impurity formation during API synthesis.

Basic Information

Product Name	Loxoprofen Ring-Opening Impurity
CAS No.	1091621-61-2
Molecular Formula	C15H18O3
Molecular Weight	246.30 g/mol
Synonyms	2-[4-[(2-Oxocyclopentyl)methyl]phenyl]propanoic Acid; Loxoprofen Related Compound A; Loxoprofen Impurity A; Loxoprofen Ring-Opened Degradant; Loxoprofen Degradation Product; (RS)-2-[4-[(2-Oxocyclopentyl)methyl]phenyl]propionic Acid
EINECS	Contact for details

Quality Control

Our Loxoprofen Ring-Opening Impurity is manufactured under strict quality systems to meet the exacting standards of pharmaceutical analysis. Each batch is subjected to comprehensive testing including identification, purity assay, and related substance analysis via validated chromatographic methods (HPLC, LC-MS). A comprehensive Certificate of Analysis (COA) is provided, detailing all test results against established specifications. Our quality commitment aligns with cGMP principles and supports compliance with ICH, USP, and EP guidelines for reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccant conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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