Description

Levofloxacin Impurity 39 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 quality control testing. The precise characterization of this impurity is essential for meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control and release testing of Levofloxacin API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to accurately identify and quantify Levofloxacin Impurity 39.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions as per ICH guidelines.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing a characterized impurity for identification and qualification.
• Research & Development: Used in R&D laboratories to study the degradation pathways, synthesis, and chemical behavior of Levofloxacin-related compounds.
• Pharmacopeial Testing: Serves as a system suitability standard for testing procedures outlined in USP, EP, or other pharmacopeias for Levofloxacin.

Basic Information

Product Name	Levofloxacin Impurity 39
CAS No.	165071-04-5
Molecular Formula	C18H20FN3O4
Molecular Weight	361.37 g/mol
Synonyms	Levofloxacin Related Compound 39; (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 Impurity; 1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic Acid Impurity; Levofloxacin EP Impurity I; Levofloxacin USP Related Compound C; Ofloxacin Impurity (Levo Isomer); (S)-(-)-Ofloxacin Impurity
EINECS	Contact for details

Quality Control

Every batch of Levofloxacin Impurity 39 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. 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 at controlled room temperature, typically between 15-25°C (59-77°F). Keep the container in a dry, cool, and well-ventilated area. For long-term storage under inert atmosphere, please contact us for specific recommendations.

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)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.2%

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