Description

Lomefloxacin Impurity 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 primarily required by pharmaceutical manufacturers, quality control laboratories, and research institutions engaged in drug development and impurity profiling. The material is supplied with comprehensive analytical data to support method validation and regulatory submissions.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control and release testing of Lomefloxacin API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating HPLC, UPLC, or LC-MS methods for impurity identification and quantification.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing identified impurity markers for stability studies and specification setting.
• Research & Degradation Studies: Employed in forced degradation studies to understand the stability profile and degradation pathways of Lomefloxacin.
• Pharmacopoeial Testing: Used in testing to meet the requirements of various pharmacopoeias (e.g., USP, EP, BP) for related substance analysis.

Basic Information

Product Name	Lomefloxacin Impurity
CAS No.	195259-11-1
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; 3-Quinolinecarboxylic acid, 1-ethyl-6,8-difluoro-1,4-dihydro-7-(3-methyl-1-piperazinyl)-4-oxo-; Lomefloxacin Process Impurity
EINECS	Contact for details

Quality Control

Every batch of our Lomefloxacin Impurity (CAS 195259-11-1) is manufactured and tested under strict quality management systems. The material undergoes rigorous analytical characterization using techniques such as HPLC, NMR, and MS to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality standards are designed to meet the requirements for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. The container should be kept tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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