Description

Enoxacin Impurity 4 is a specified impurity and degradation product of the fluoroquinolone antibiotic Enoxacin. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method validation and quality control. It is primarily used by analytical chemists, quality assurance professionals, and R&D scientists in the pharmaceutical and contract research organization (CRO) sectors to ensure the purity, safety, and efficacy of Enoxacin API and its formulations.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Enoxacin Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, calibrating, and validating chromatographic methods to monitor impurity profiles and ensure compliance with ICH Q3A/B guidelines.
• Quality Control & Batch Release Testing: Employed in routine QC laboratories to confirm the impurity levels in production batches are within specified limits.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability profiling.
• Regulatory Submissions: Provides necessary data on impurity characterization for regulatory filings with agencies like the FDA, EMA, and other global health authorities.
• Research on Degradation Pathways: Aids in studying the chemical stability and degradation mechanisms of Enoxacin.

Basic Information

Product Name	Enoxacin Impurity 4
CAS No.	87939-21-7
Molecular Formula	C15H17FN4O3
Molecular Weight	320.32 g/mol
Synonyms	1-Ethyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-1,8-naphthyridine-3-carboxylic Acid; Enoxacin Related Compound; Enoxacin EP Impurity; Enoxacin USP Impurity; Enoxacin Degradation Product; 1-Ethyl-6-fluoro-4-oxo-7-piperazin-1-yl-1,8-naphthyridine-3-carboxylic Acid
EINECS	Contact for details

Quality Control

Every batch of Enoxacin Impurity 4 is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data, including HPLC purity, identity confirmation (IR, NMR, MS), and residual solvent analysis, to ensure the material meets the stringent requirements for use as a reference standard. A detailed Certificate of Analysis (COA) with batch-specific data is supplied with each shipment, supporting compliance with cGMP and ICH guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

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)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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