Description

Gatifloxacin Impurity J is a high-purity chemical reference standard, specifically identified as a process-related impurity of the fluoroquinolone antibiotic Gatifloxacin. 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, quality assurance laboratories, and regulatory affairs professionals within the global pharmaceutical and fine chemical industries.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Gatifloxacin Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) to meet ICH Q3A(R2) and Q3B(R2) guidelines.
• Used in stability studies and forced degradation studies to understand the degradation pathways of Gatifloxacin.
• Essential for pharmaceutical quality control (QC) and quality assurance (QA) laboratories to establish impurity profiles and release specifications.
• Serves as a key starting material or intermediate in organic synthesis research for novel fluoroquinolone derivatives.
• Supports regulatory submissions (e.g., to FDA, EMA) by providing definitive impurity characterization data.

Basic Information

Product Name	Gatifloxacin Impurity J
CAS No.	114213-77-3
Molecular Formula	C19H22FN3O4
Molecular Weight	375.40 g/mol
Synonyms	1-Cyclopropyl-6-fluoro-8-methoxy-7-(3-methylpiperazin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid; AM-1155 Impurity J; Gatifloxacin Related Compound J; 1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic Acid; (RS)-1-Cyclopropyl-6-fluoro-8-methoxy-7-(3-methylpiperazin-1-yl)-4-oxoquinoline-3-carboxylic Acid; (±)-Gatifloxacin Impurity J; Gatifloxacine Impurity J
EINECS	Contact for details

Quality Control

Every batch of Gatifloxacin Impurity J is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and residual solvents.

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 must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

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)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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