Description

Levofloxacin Impurity 4 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 studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Levofloxacin API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and other chromatographic methods in quality control laboratories.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Stability Studies: Employed to monitor the formation and levels of this impurity during forced degradation and long-term stability testing of Levofloxacin formulations.
• Research & Development: Used in R&D to study the degradation pathways, synthesis impurities, and metabolic byproducts of Levofloxacin.
• Quality Control & Batch Release: Acts as a system suitability standard and a calibrant for routine quality control testing to ensure batch-to-batch consistency.

Basic Information

Product Name	Levofloxacin Impurity 4
CAS No.	2206135-16-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Levofloxacin Related Compound 4; Levofloxacin EP Impurity D; Levofloxacin USP Impurity; (S)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid impurity; Levofloxacin Degradant; Levofloxacin Process Impurity; Tavanic Impurity
EINECS	Contact for details

Quality Control

Our Levofloxacin Impurity 4 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via spectroscopic methods (NMR, MS). We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, ensuring traceability and compliance with ICH guidelines and pharmacopeial standards for impurity reference materials.

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 product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle under an inert atmosphere if necessary for long-term storage.

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)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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