Description

Gatifloxacin Related Compound A is a high-purity chemical reference standard, identified by CAS No. 616205-76-6. This compound is critical for ensuring the quality, safety, and efficacy of the fluoroquinolone antibiotic Gatifloxacin through rigorous analytical testing. It is an essential material for pharmaceutical manufacturers and quality control laboratories engaged in research, development, and regulatory compliance. The precise characterization of this related substance is fundamental to meeting pharmacopeial standards and safeguarding pharmaceutical supply chains.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Gatifloxacin Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating High-Performance Liquid Chromatography (HPLC), UPLC, and other chromatographic methods for purity analysis.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity profiles and ensure compliance with stringent pharmacopeial specifications (e.g., USP, EP, JP).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA) to demonstrate control over the manufacturing process.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions, supporting shelf-life determination.
• Research & Development: Facilitates studies on the metabolism, degradation pathways, and synthesis of Gatifloxacin and its analogs.

Basic Information

Product Name	Gatifloxacin Related Compound A
CAS No.	616205-76-6
Molecular Formula	C19H22FN3O4
Molecular Weight	375.40 g/mol
Synonyms	1-Cyclopropyl-6-fluoro-7-[(3S,4R)-3-methyl-4-(methylamino)piperidin-1-yl]-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid; Gatifloxacin Impurity A; Gatifloxacin EP Impurity A; Gatifloxacin USP Related Compound A; (3S,4R)-1-Cyclopropyl-6-fluoro-8-methoxy-7-(3-methyl-4-methylaminopiperidin-1-yl)-4-oxoquinoline-3-carboxylic acid; Gatifloxacin Process Impurity; Desmethyl Gatifloxacin
EINECS	Contact for details

Quality Control

Every batch of Gatifloxacin Related Compound A is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing to ensure compliance with relevant pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results for purity (HPLC), identification (IR, NMR), and related substances is provided with each shipment to support your regulatory and quality requirements.

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. For long-term storage, consider conditions under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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