Description

Lomefloxacin Impurity 3 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 material is essential for method development, validation, and impurity profiling studies in accordance with ICH guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Lomefloxacin Impurity 3 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: A critical component for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities in Lomefloxacin.
• Quality Control & Assurance: Employed in routine QC testing to ensure Lomefloxacin batches meet stringent pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and marketing authorization applications.
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Research & Process Chemistry: Aids in understanding the degradation pathways of Lomefloxacin and optimizing synthesis processes to minimize impurity formation.

Basic Information

Product Name	Lomefloxacin Impurity 3
CAS No.	183235-15-6
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 3; Lomefloxacin Related Compound 3; Lomefloxacin EP Impurity C; Lomefloxacin USP Impurity; 7-(3-Methylpiperazin-1-yl)-1-ethyl-6,8-difluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid Impurity; Lomefloxacin Degradation Product; Fluoroquinolone Impurity
EINECS	Contact for details

Quality Control

Our Lomefloxacin Impurity 3 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via MS and NMR, 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, analytical methods, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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