Description

Gatifloxacin Dimer 1 is a high-purity chemical reference standard and a key synthetic intermediate in the production of advanced pharmaceutical compounds. This compound is critical for research and development, particularly in the synthesis and quality control of fluoroquinolone antibiotics. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions focused on antimicrobial development and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of dimeric impurities in Gatifloxacin API and finished drug products.
• Analytical Research: Serves as a critical standard in method development and validation for HPLC, LC-MS, and other chromatographic techniques in quality control laboratories.
• Process Chemistry & R&D: Employed as a building block or intermediate in the research-scale synthesis of novel fluoroquinolone derivatives and related antimicrobial agents.
• Regulatory Compliance: Essential for conducting stability studies and impurity fate mapping to meet ICH guidelines and regulatory submission requirements (e.g., FDA, EMA).
• Academic Research: Used in universities and research institutes for studies on antibiotic degradation pathways, metabolite formation, and structure-activity relationships.

Basic Information

Product Name	Gatifloxacin Dimer 1
CAS No.	1497338-46-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Gatifloxacin Dimer; Gatifloxacin Impurity Dimer 1; 1-Cyclopropyl-6-fluoro-8-methoxy-7-(3-methylpiperazin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid dimer; Gatifloxacin Related Compound Dimer; Fluoroquinolone Dimer Impurity; Antibiotic Impurity Dimer; GAT Dimer 1
EINECS	Contact for details

Quality Control

Our Gatifloxacin Dimer 1 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the stringent requirements for use as a reference standard. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and regulatory compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

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)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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