Description

Lomefloxacin Impurity 8 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, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The precise characterization of this impurity is essential for maintaining the highest standards in pharmaceutical production and quality control.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of Lomefloxacin.
• Impurity Profiling: Essential for identifying and quantifying process-related impurities in Lomefloxacin Active Pharmaceutical Ingredient (API) batches.
• Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or other chromatographic methods for quality control.
• Stability Studies: Employed to monitor the formation of degradation products in Lomefloxacin formulations under various storage conditions.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity identification and control strategies.
• Research & Development: Used in academic and industrial R&D to study the metabolism, degradation pathways, and chemical behavior of Lomefloxacin.

Basic Information

Product Name	Lomefloxacin Impurity 8
CAS No.	195259-19-9
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 8; Lomefloxacin Related Compound 8; Lomefloxacin EP Impurity I; Lomefloxacin USP Impurity; (RS)-1-Ethyl-6,8-difluoro-1,4-dihydro-7-(3-methylpiperazin-1-yl)-4-oxoquinoline-3-carboxylic Acid Impurity; Decarboxylated Lomefloxacin Impurity; LFX Imp-8
EINECS	Contact for details

Quality Control

Every batch of Lomefloxacin Impurity 8 is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing, including identity confirmation by spectroscopic methods (IR, NMR, MS) and purity determination by advanced chromatographic techniques (HPLC, UPLC) to ensure it meets the stringent requirements for a reference standard. 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, typically between 15°C and 25°C (59°F and 77°F), in a dry environment. For long-term storage, consider storing at 2°C to 8°C. Keep the container tightly sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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