Description

Gatifloxacin Impurity 1 CAS NO 1335198-95-2 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the antibiotic Gatifloxacin by accurately identifying and quantifying this specific impurity during pharmaceutical development and manufacturing. It is an essential material for analytical chemists, quality assurance professionals, and researchers in the pharmaceutical industry focused on method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Gatifloxacin Impurity 1 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Crucial for developing, validating, and transferring analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity levels and ensure drug product specifications are met according to ICH, USP, and EP guidelines.
• Stability Studies: Employed to track the formation and increase of this impurity over time under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for impurity identification and qualification reports required by regulatory bodies like the FDA and EMA.
• Research & Development (R&D): Supports synthetic route optimization and process chemistry studies by understanding impurity formation pathways.

Basic Information

Item	Detail
Product Name	Gatifloxacin Impurity 1
CAS No.	1335198-95-2
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; Gatifloxacin Related Compound A; Gatifloxacin EP Impurity A; Gatifloxacin USP Impurity A; AM-1155 Impurity; GTX Impurity 1; (3-Methylpiperazin-1-yl) Gatifloxacin Analog
EINECS	Contact for details

Quality Control

Every batch of Gatifloxacin Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B, USP, and EP guidelines for impurities in new drug substances.

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 under inert conditions or in a desiccator to prevent degradation. For long-term storage, consider storing at 2-8°C.

Specification

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

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