Description

Levofloxacin Impurity 7 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 (API) 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 maintaining the highest standards in pharmaceutical production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Levofloxacin API and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles in compliance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch testing in pharmaceutical quality control laboratories.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Employed to track the formation and level of this specific impurity during forced degradation and long-term stability testing of Levofloxacin formulations.
• Research & Development: Used in pharmacokinetic, metabolic, and toxicological studies to understand the impact of the impurity.

Basic Information

Product Name	Levofloxacin Impurity 7
CAS No.	1607796-83-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Levofloxacin Related Compound 7; Levofloxacin EP Impurity G; 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; Levofloxacin Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Levofloxacin Impurity 7 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC and LC-MS to ensure compliance with pharmacopeial standards (USP, EP). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each 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 container should be kept in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (MS)	Conforms
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.