Description

Levofloxacin Impurity 9 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 in drug development and production.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Levofloxacin API and finished dosage forms.
• Essential for analytical method development and validation (HPLC, LC-MS) in pharmaceutical quality control laboratories.
• Used in stability studies and forced degradation studies to understand the degradation profile of Levofloxacin.
• Serves as a critical material for regulatory submissions (e.g., ANDA, NDA) to health authorities like the US FDA and EMA.
• Supports research and development activities aimed at improving synthetic pathways and purification processes for Levofloxacin.
• Utilized by contract research organizations (CROs) and testing laboratories offering compliance and batch release services.

Basic Information

Product Name	Levofloxacin Impurity 9
CAS No.	1797099-76-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Levofloxacin Related Compound 9; Levofloxacin EP Impurity J; 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 Process Impurity; Levofloxacin Degradant; OFX Impurity
EINECS	Contact for details

Quality Control

Every batch of Levofloxacin Impurity 9 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including relevant pharmacopeial guidelines (USP, EP). Comprehensive characterization is performed using advanced techniques like HPLC, LC-MS, and NMR. Certificates of Analysis (COA) detailing purity, identity, and impurity profile are available upon request.

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. Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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