Description

Pefloxacin Impurity B 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, Pefloxacin. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments engaged in method development, validation, and impurity profiling. Our supply guarantees the reliability and traceability required for stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Pefloxacin Impurity B in active pharmaceutical ingredient (API) and finished drug product analysis.
• Method Development and Validation: Used in developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Ultra-Performance Liquid Chromatography (UPLC), to meet ICH Q2(R1) guidelines.
• Quality Control & Assurance: Employed in routine batch release testing to monitor and control impurity levels, ensuring drug substance and product specifications are met.
• Regulatory Compliance and Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies as per ICH Q3A/B.
• Stability Studies: Used as a marker to track impurity formation during forced degradation and long-term stability studies of Pefloxacin.
• Research and Development: Utilized in synthetic chemistry research to study degradation pathways and to develop improved purification processes for Pefloxacin API.

Basic Information

Product Name	Pefloxacin Impurity B
CAS No.	70458-73-0
Molecular Formula	C17H20FN3O3
Molecular Weight	333.36 g/mol
Synonyms	1-Ethyl-6-fluoro-7-(4-methylpiperazin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid; Pefloxacin Related Compound B; 1-Ethyl-6-fluoro-1,4-dihydro-7-(4-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic Acid; Pefloxacin EP Impurity B; Pefloxacin USP Impurity B; Pefloxacin Impurity 2; 1-Ethyl-6-fluoro-7-(4-methylpiperazin-1-yl)-4-oxoquinoline-3-carboxylic Acid
EINECS	Contact for details

Quality Control

Every batch of Pefloxacin Impurity B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing to ensure compliance with pharmacopeial standards (USP, EP) and ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC purity, related substances, residual solvents, and other critical tests.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

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

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