Description

Sitafloxacin Impurity 12 is a specified impurity of the broad-spectrum fluoroquinolone antibiotic, Sitafloxacin. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Sitafloxacin drug substances and finished products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Sitafloxacin API and formulations.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and other chromatographic methods for impurity profiling.
• Quality Control & Assurance: A critical component in routine QC testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing impurity characterization data.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions.
• Research & Development: Used in synthetic chemistry research to study the formation pathways and properties of Sitafloxacin-related substances.

Basic Information

Product Name	Sitafloxacin Impurity 12
CAS No.	2008714-64-3
Molecular Formula	C19H18ClF2N3O3
Molecular Weight	409.81 g/mol
Synonyms	7-[(7S)-7-Amino-5-azaspiro[2.4]heptan-5-yl]-8-chloro-6-fluoro-1-[(1R,2S)-2-fluorocyclopropyl]-4-oxo-1,4-dihydroquinoline-3-carboxylic acid; Sitafloxacin Related Compound 12; Sitafloxacin EP Impurity J; Sitafloxacin USP Impurity; DU-6859a Impurity; (1R,2S,7S)-8-Chloro-6-fluoro-1-(2-fluorocyclopropyl)-7-(5-azaspiro[2.4]heptan-7-ylamino)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid
EINECS	Contact for details

Quality Control

Every batch of Sitafloxacin Impurity 12 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, NMR, and MS to ensure compliance with pharmacopeial standards (e.g., USP, EP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

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)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm

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