Description

Besifloxacin 8-Dechloro Impurity is a key process-related impurity and degradation product of the fluoroquinolone antibiotic Besifloxacin. This compound is critical for pharmaceutical research and development, serving as a certified reference standard for analytical method development, validation, and quality control. It is essential for manufacturers, analytical laboratories, and regulatory bodies involved in ensuring the purity, safety, and efficacy of Besifloxacin-based ophthalmic solutions and other pharmaceutical formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for HPLC, LC-MS, and other chromatographic analyses.
• Method Development & Validation: Critical for developing and validating stability-indicating assay methods for Besifloxacin drug substance and finished products.
• Quality Control & Batch Release: Used in pharmaceutical QC labs to monitor and quantify the 8-Dechloro impurity level during drug substance synthesis and formulation.
• Stability Studies: Employed to identify and track this specific degradation product in forced degradation and long-term stability studies of Besifloxacin.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization and control data.
• Research on Degradation Pathways: Used in academic and industrial research to study the degradation mechanisms and stability profile of fluoroquinolone antibiotics.

Basic Information

Product Name	Besifloxacin 8-Dechloro Impurity
CAS No.	141388-69-4
Molecular Formula	C19H21FN2O3
Molecular Weight	344.38 g/mol
Synonyms	8-Deschloro Besifloxacin; 1-Cyclopropyl-7-[(3R,4S)-3-(methylamino)-4-(methylsulfonyl)pyrrolidin-1-yl]-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid; BAY y 3118 8-Dechloro Impurity; (R,S)-7-(3-Amino-4-methylsulfonylpyrrolidin-1-yl)-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid 8-Dechloro Derivative; Besifloxacin Deschloro Impurity; Besifloxacin Related Compound C (Potential)
EINECS	Contact for details

Quality Control

Our Besifloxacin 8-Dechloro Impurity is manufactured under strict quality systems suitable for use as a pharmaceutical reference standard. Each batch undergoes comprehensive analytical characterization using techniques including HPLC, LC-MS, NMR, and IR to confirm identity and purity. A detailed Certificate of Analysis (COA) is provided, containing batch-specific data on purity, impurities, and chromatographic profiles. We support compliance with ICH Q3A/B, USP, and EP guidelines for impurities in new drug substances and products.

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 should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider storing under inert atmosphere at -20°C.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown 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.