Description

Delafloxacin Impurity 4 is a specified impurity and degradation product of the fluoroquinolone antibiotic Delafloxacin. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, stability studies, and quality control. It is essential for manufacturers, analytical laboratories, and regulatory bodies involved in ensuring the purity, safety, and efficacy of Delafloxacin API and finished drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Delafloxacin active pharmaceutical ingredient (API).
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, and other chromatographic methods to monitor impurity profiles.
• Stability Studies & Forced Degradation: Used to understand degradation pathways of Delafloxacin under various stress conditions (e.g., heat, light, humidity).
• Quality Control & Batch Release: Enables precise impurity profiling to ensure batches comply with stringent pharmacopeial (USP, EP) and ICH Q3A/B guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing definitive impurity characterization data.
• Research on Degradation Mechanisms: Facilitates academic and industrial research into the chemical behavior and stability of fluoroquinolone antibiotics.

Basic Information

Product Name	Delafloxacin Impurity 4
CAS No.	959374-64-2
Molecular Formula	C18H12ClF3N4O4
Molecular Weight	440.76 g/mol
Synonyms	1-Deoxy-1-(methylamino)-Delafloxacin; Delafloxacin Related Compound D; 1-(6-Amino-3,5-difluoropyridin-2-yl)-8-chloro-6-fluoro-7-(3-hydroxyazetidin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid; 8-Chloro-6-fluoro-1-(6-((methylamino)methyl)-3,5-difluoropyridin-2-yl)-7-(3-hydroxyazetidin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid; Delafloxacin Impurity D; ABT-492 Impurity 4
EINECS	Contact for details

Quality Control

Our Delafloxacin Impurity 4 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Each batch is characterized and qualified using advanced techniques including HPLC, MS, and NMR. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, impurity profile, and analytical data, supporting compliance with ICH Q3A, Q3B, and relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. For long-term storage, consider storing desiccated at -20°C. Handle with appropriate precautions in a well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 2.0%
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.