Description

Levofloxacin Tetrafluoro Impurity 2 CAS NO 103995-33-1 is a critical pharmaceutical reference standard and impurity used in the quality control of the antibiotic Levofloxacin. This compound is essential for analytical method development, validation, and ensuring the purity and safety of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, development, and quality assurance processes.

Application

• Pharmaceutical Impurity Profiling and Identification in Levofloxacin API and finished dosage forms.
• Analytical Method Development and Validation (HPLC, LC-MS) for accurate quantification of related substances.
• Quality Control and Release Testing to comply with pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Stability Studies to monitor impurity formation under various stress conditions.
• Regulatory Submissions as a characterized impurity for drug master files (DMFs) and marketing applications.
• Research and Development of Levofloxacin synthesis pathways and degradation studies.
• Calibration Standard for ensuring the accuracy and precision of analytical instrumentation.

Basic Information

Product Name	Levofloxacin Tetrafluoro Impurity 2
CAS No.	103995-33-1
Molecular Formula	C18H20F4N3O4
Molecular Weight	418.37 g/mol
Synonyms	Levofloxacin Impurity 2; Levofloxacin Tetrafluoro Impurity; (3S)-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 tetrafluoro impurity; Levofloxacin Related Compound 2; OFX Impurity 2; Levofloxacin EP Impurity B; Levofloxacin USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Levofloxacin Tetrafluoro Impurity 2 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and compliance with industry standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH guidelines and pharmacopeial requirements for pharmaceutical impurities.

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)	Conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	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.