Description

Enoxacin Impurity 8 is a specified impurity of the broad-spectrum fluoroquinolone antibiotic, Enoxacin. This compound is of critical importance for pharmaceutical research and development, serving as a certified reference standard for analytical and quality control purposes. It is essential for laboratories and manufacturers involved in method development, stability studies, and ensuring the purity and safety of Enoxacin API and finished drug products.

Application

• Primary use as a certified reference standard (CRS) for the identification and quantification of Enoxacin Impurity 8 in active pharmaceutical ingredients (API).
• Critical component in analytical method development and validation for HPLC, UPLC, and LC-MS systems.
• Essential for conducting stability studies and impurity profiling to meet ICH Q3A(R2) and Q3B(R2) guidelines.
• Used in pharmaceutical quality control (QC) laboratories to ensure batch-to-batch consistency and regulatory compliance.
• Valuable for research and development into the degradation pathways and metabolism of Enoxacin.
• Serves as a calibration standard in pharmacokinetic and bioanalytical studies.

Basic Information

Product Name	Enoxacin Impurity 8
CAS No.	115274-26-5
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 Impurity; Enoxacin Related Compound; 1-Ethyl-6-fluoro-4-oxo-7-piperazin-1-yl-1,8-naphthyridine-3-carboxylic Acid Impurity; Enoxacin EP Impurity; Enoxacin USP Impurity; AT-2266 Impurity; CI-919 Impurity; Flumark Impurity
EINECS	Contact for details

Quality Control

Every batch of Enoxacin Impurity 8 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC and LC-MS to ensure they meet the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. Handle the material in accordance with good laboratory practices.

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%
Residue on Ignition	≤ 0.5%

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