Description

(3S)-10-(4-Ethyl-1-Piperazinyl)-9-Fluoro-2,3-Dihydro-3-Methyl-7-Oxo-7H-Pyrido[1,2,3-De]-1,4-Benzoxazine-6-Carboxylic Acid (Levofloxacin Impurity) is a high-purity chemical reference standard critical for analytical and quality control processes in the pharmaceutical industry. This compound serves as a specified impurity of the broad-spectrum antibiotic Levofloxacin, making it essential for ensuring drug safety, efficacy, and regulatory compliance. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing. Supplying this impurity with documented traceability and purity is fundamental to supporting robust pharmacopeial compliance and Good Manufacturing Practice (GMP).

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify this specific impurity in Levofloxacin Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or other chromatographic methods per ICH Q2(R1) guidelines.
• Quality Control and Batch Release Testing: Employed in routine QC laboratories to test Levofloxacin batches against stringent pharmacopeial limits for related substances (e.g., USP, EP, JP).
• Stability Studies and Degradation Pathway Analysis: Acts as a marker to study the stability of Levofloxacin under various stress conditions (hydrolysis, oxidation, photolysis) as per ICH Q1A(R2).
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity characterization and control strategies for Levofloxacin.
• Research and Development: Utilized in pharmaceutical R&D for synthetic route optimization, process-related impurity studies, and the development of generic formulations.

Basic Information

Product Name	(3S)-10-(4-Ethyl-1-Piperazinyl)-9-Fluoro-2,3-Dihydro-3-Methyl-7-Oxo-7H-Pyrido[1,2,3-De]-1,4-Benzoxazine-6-Carboxylic Acid (Levofloxacin Impurity)
CAS No.	106939-30-4
Molecular Formula	C21H24FN3O4
Molecular Weight	401.43 g/mol
Synonyms	Levofloxacin Impurity; Levofloxacin Related Compound; (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 (Isomer); OFX Acid 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; Levofloxacin EP Impurity; Levofloxacin USP Impurity
EINECS	Contact for details

Quality Control

This high-purity reference standard is manufactured and controlled under a strict quality management system. Each batch undergoes comprehensive analytical testing, including HPLC for purity and related substances, NMR and MS for structural confirmation, and loss on drying. We provide full traceability and compliance with relevant guidelines. A comprehensive Certificate of Analysis (COA) detailing all test results, methods, and specifications is supplied with every shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The product is hygroscopic (moisture-sensitive) and should be handled in a dry environment 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 impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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