Description

Sparfloxacin Impurity CAS NO 126457-99-6 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the fluoroquinolone antibiotic, Sparfloxacin. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, validation, and impurity profiling. The availability of a well-characterized impurity standard is fundamental for meeting stringent pharmacopeial requirements and maintaining batch-to-batch consistency.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference standard for the identification and quantification of specific impurities in Sparfloxacin Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Used as a critical component in developing and validating HPLC, UPLC, or other chromatographic methods for Sparfloxacin analysis.
• Quality Control and Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure compliance with specifications from USP, EP, ICH, or other regulatory guidelines.
• Stability Studies: Utilized as a marker to track the formation of degradation products during forced degradation and long-term stability studies of Sparfloxacin formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) by characterizing and controlling impurities as per ICH Q3A and Q3B guidelines.
• Research and Development: Supports chemical research into the synthesis, metabolism, and degradation pathways of fluoroquinolone antibiotics.

Basic Information

Product Name	Sparfloxacin Impurity
CAS No.	126457-99-6
Molecular Formula	C19H22F2N4O3
Molecular Weight	392.40 g/mol
Synonyms	1-Cyclopropyl-7-[(3R,5S)-3,5-dimethylpiperazin-1-yl]-6-fluoro-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid; Sparfloxacin Related Compound; Sparfloxacin Degradant; Sparfloxacin Process Impurity; (R,S)-Sparfloxacin Impurity; 5-Amino-1-cyclopropyl-7-[(3R,5S)-3,5-dimethylpiperazin-1-yl]-6-fluoro-8-methoxy-4-oxoquinoline-3-carboxylic acid (common name for related structure); AT-4140 Impurity
EINECS	Contact for details

Quality Control

Our Sparfloxacin Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity determination and spectroscopic methods (NMR, MS) for structural confirmation, to ensure identity, purity, and consistency. We provide comprehensive Certificates of Analysis (COA) with each shipment, detailing batch-specific results. The material is suitable for use as a reference standard in compliance with ICH Q3A, Q3B, USP, and EP guidelines for impurity control.

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 light-sensitive; therefore, containers must be kept tightly sealed and stored in a desiccated environment away from direct light exposure 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 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.