Description

Lomefloxacin Impurity CAS NO 111234-01-6 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 fluoroquinolone antibiotic Lomefloxacin. It is an essential tool for pharmaceutical manufacturers, quality control (QC) laboratories, and research institutions involved in drug development and impurity profiling. The material is supplied with comprehensive analytical data to support method validation and regulatory submissions.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material to identify, quantify, and monitor this specific impurity in Lomefloxacin Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to ensure accurate impurity detection.
• Quality Control and Assurance (QC/QA): Employed in routine batch release testing within pharmaceutical manufacturing to verify that impurity levels are within specified pharmacopeial limits (e.g., ICH Q3A/B).
• Stability Studies: Used to track the formation and growth of this impurity over time under various stress conditions, supporting drug shelf-life determination.
• Regulatory Compliance and Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development (R&D): Utilized in synthetic chemistry and degradation pathway studies to understand the formation mechanism and chemical behavior of this impurity.

Basic Information

Product Name	Lomefloxacin Impurity
CAS No.	111234-01-6
Molecular Formula	C17H19F2N3O3
Molecular Weight	351.35 g/mol
Synonyms	1-Ethyl-6,8-difluoro-1,4-dihydro-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic Acid Impurity; Lomefloxacin Related Compound; Lomefloxacin EP Impurity; Lomefloxacin USP Impurity; 1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(3-methylpiperazin-1-yl)-4-oxoquinoline-3-carboxylic Acid Impurity (Structural Isomer); Lomefloxacin Degradation Product; Fluoroquinolone Impurity Standard
EINECS	Contact for details

Quality Control

Every batch of Lomefloxacin Impurity (CAS 111234-01-6) is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, impurities, and other critical parameters. Our quality commitment aligns with ICH guidelines and supports compliance with global pharmacopeial standards (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to maximize stability.

Specification

Item	Specification
Appearance	White to Off-white powder
Identification (IR)	Conforms to Reference Spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 2.0% w/w
Residue on Ignition	≤ 0.5%

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