Description

Sitafloxacin Impurity 5 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 active pharmaceutical ingredient, Sitafloxacin, by serving as a known benchmark in impurity profiling. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and quality control departments engaged in method development, validation, and batch release testing.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material to identify and quantify related substances in Sitafloxacin API batches.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods for Sitafloxacin analysis.
• Quality Control and Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure product specifications are met.
• Regulatory Compliance and Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing data for impurity characterization as per ICH guidelines.
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions and during shelf-life studies.
• Research and Development: Facilitates chemical and pharmacological research to understand the properties and potential impact of this impurity.

Basic Information

Product Name	Sitafloxacin Impurity 5
CAS No.	1630983-99-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sitafloxacin Related Compound 5; Sitafloxacin EP Impurity 5; Sitafloxacin USP Impurity 5; Sitafloxacin Process Impurity; 7-[(4S)-2,8-Diazabicyclo[4.3.0]non-8-yl]-8-chloro-6-fluoro-1-[(1R,2S)-2-fluorocyclopropyl]-4-oxo-1,4-dihydroquinoline-3-carboxylic acid impurity; DU-6859a Impurity; Gracevit Impurity
EINECS	Contact for details

Quality Control

Our Sitafloxacin Impurity 5 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and chromatographic data is provided with every shipment to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits

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