Description

Besifloxacin Impurity F Hcl is a high-purity chemical reference standard specifically identified as a process-related impurity of the fluoroquinolone antibiotic, Besifloxacin. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing, ensuring the safety and efficacy of the final drug product. It is an essential material for research and development scientists, analytical chemists, and quality assurance professionals in the pharmaceutical and fine chemical industries who require reliable reference standards for impurity profiling and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Besifloxacin Impurity F in active pharmaceutical ingredient (API) and finished drug product analysis.
• Analytical Method Development: Used to develop and validate sensitive HPLC, UPLC, or LC-MS methods for impurity detection and profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance: Serves as a system suitability standard and for routine quality control testing to monitor impurity levels throughout the API synthesis and purification process.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings with agencies such as the FDA, EMA, and PMDA.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific impurity under various stress conditions.
• Research & Development: Used in chemical research to study the degradation pathways and metabolism of Besifloxacin.

Basic Information

Product Name	Besifloxacin Impurity F Hcl
CAS No.	1613314-38-7
Molecular Formula	C19H21ClFN3O3 • HCl
Molecular Weight	426.31 g/mol (Free base: 389.84 g/mol)
Synonyms	7-[(3R)-3-Amino-4-(2,4-difluorophenyl)-1-pyrrolidinyl]-8-chloro-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid hydrochloride; Besifloxacin Related Compound F HCl; Besifloxacin EP Impurity F HCl; Besifloxacin USP Impurity F HCl; (R)-7-(3-Amino-4-(2,4-difluorophenyl)pyrrolidin-1-yl)-8-chloro-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Besifloxacin Impurity F Hcl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques (HPLC, LC-MS, NMR) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting its use as a pharmaceutical reference standard.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This 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 (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC, Area %)	≥ 98.0%
Assay (on dried basis)	97.0% - 102.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual unknown impurity ≤ 0.10% Total impurities ≤ 1.0%

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