Description

Sitafloxacin Impurity 11 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 (API) Sitafloxacin. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Sitafloxacin API batches.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods for Sitafloxacin analysis.
• Quality Control & Assurance (QC/QA): Essential for in-house quality control laboratories to monitor impurity levels and ensure batch-to-batch consistency.
• Regulatory Compliance & Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Employed in forced degradation and long-term stability studies of Sitafloxacin to understand impurity formation pathways.
• Research & Development: Used in pharmaceutical R&D for studying the degradation chemistry and metabolic pathways of fluoroquinolone antibiotics.

Basic Information

Product Name	Sitafloxacin Impurity 11
CAS No.	105919-33-3
Molecular Formula	C19H18F3N3O3
Molecular Weight	393.36 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; DU-6859a Impurity; (1R,2S,7S)-7-[(7-Amino-5-azaspiro[2.4]hept-5-yl)]-8-chloro-6-fluoro-1-(2-fluorocyclopropyl)-1,4-dihydro-4-oxo-3-quinolinecarboxylic Acid; Sitafloxacin EP Impurity; Sitafloxacin USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Sitafloxacin Impurity 11 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity screening to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC, NMR, and MS testing.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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