Description

Lomefloxacin Impurity CAS NO 195259-12-2 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 R&D laboratories, quality control (QC) departments, and regulatory affairs teams. The impurity standard is essential for method development, validation, and monitoring the purity profile of the active pharmaceutical ingredient (API) and finished drug products.

Application

• Pharmaceutical Quality Control (QC): Used as a certified reference material for the identification and quantification of specific impurities in Lomefloxacin API and formulated drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity profiles and control strategies.
• Stability Studies: Employed to monitor the formation of degradation products in Lomefloxacin under various stress conditions over time.
• Research & Development: Used in chemical and pharmacological research to study the metabolism, degradation pathways, and synthesis of Lomefloxacin.
• Pharmacopoeial Standards: Can be utilized as a working standard in conjunction with official pharmacopoeial monographs (e.g., USP, EP) for impurity testing.

Basic Information

Product Name	Lomefloxacin Impurity
CAS No.	195259-12-2
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 Process Impurity; Lomefloxacin Degradant; 3-Quinolinecarboxylic acid, 1-ethyl-6,8-difluoro-1,4-dihydro-7-(3-methyl-1-piperazinyl)-4-oxo-; Lomefloxacin Analog
EINECS	Contact for details

Quality Control

Our Lomefloxacin Impurity standard is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and spectroscopic methods (NMR, MS) for structural verification, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. Keep the container sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%

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