Description

Levofloxacin Related Compound E 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 or degradation product of the broad-spectrum antibiotic Levofloxacin, enabling precise monitoring and validation of drug substance purity. It is essential for manufacturers, analytical laboratories, and regulatory bodies requiring reliable materials for method development, validation, and compliance testing. Ensuring the integrity of this compound is fundamental to maintaining the safety and efficacy profiles of final pharmaceutical products.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Levofloxacin Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing characterized impurity standards for stability studies and specification setting.
• Quality Control & Batch Release Testing: Employed in routine QC testing to ensure Levofloxacin batches meet stringent pharmacopeial (USP, EP, JP) purity requirements.
• Research & Development: Utilized in R&D for studying the degradation pathways and stability of Levofloxacin under various conditions.
• Contract Research Organization (CRO) Services: Supplied to CROs and testing laboratories offering analytical and compliance services to the pharmaceutical sector.

Basic Information

Item	Detail
Product Name	Levofloxacin Related Compound E
CAS No.	1346603-62-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Levofloxacin Impurity E; Levofloxacin EP Impurity E; Levofloxacin Related Substance E; (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 Related Compound E; Levofloxacin Degradation Product E; Levofloxacin Process Impurity E; Levofloxacin Specified Impurity E
EINECS	Contact for details

Quality Control

Our Levofloxacin Related Compound E is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay results, and chromatographic data. We support compliance with ICH guidelines and major pharmacopeias (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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