Description

Levofloxacin Impurity 11 CAS NO 106939-42-8 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 Levofloxacin. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of this well-characterized impurity standard is essential for maintaining the stringent quality control demanded in modern pharmaceutical production.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material to identify, quantify, and monitor this specific impurity in Levofloxacin API and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control and Assurance (QC/QA): Employed in routine quality control testing to ensure Levofloxacin batches meet pharmacopeial (USP, EP, JP) and internal purity specifications.
• Regulatory Compliance and Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds and control strategies.
• Stability Studies: Used to track the formation and level of this impurity during forced degradation and long-term stability studies of Levofloxacin.
• Research and Development: Facilitates research into the degradation pathways, synthesis, and toxicological profile of Levofloxacin-related compounds.

Basic Information

Product Name	Levofloxacin Impurity 11
CAS No.	106939-42-8
Molecular Formula	C18H20FN3O4
Molecular Weight	361.37 g/mol
Synonyms	Levofloxacin Related Compound J; (3S)-9-Fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid; 1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid impurity; Levofloxacin EP Impurity J; Levofloxacin USP Related Compound J
EINECS	Contact for details

Quality Control

Every batch of Levofloxacin Impurity 11 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C to ensure maximum 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)	Any individual impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%

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