Description

Norfloxacin EP Impurity K is a specified impurity and reference standard used in the quality control of the fluoroquinolone antibiotic Norfloxacin. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product in compliance with stringent pharmacopeial standards. It is primarily utilized in research, method development, and as a certified reference material for HPLC and other chromatographic analyses.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Norfloxacin EP Impurity K in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Pharmacopeial Compliance: Supports testing to meet the specifications of the European Pharmacopoeia (EP), United States Pharmacopeia (USP), and other international regulatory standards.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions during drug stability testing.
• Process Chemistry & R&D: Used in research to understand impurity profiles, optimize synthesis pathways, and ensure the purity of Norfloxacin during manufacturing.
• Regulatory Submissions: Provides necessary data and reference materials for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).

Basic Information

Product Name	Norfloxacin EP Impurity K
CAS No.	74011-48-6
Molecular Formula	C16H18FN3O3
Molecular Weight	319.33 g/mol
Synonyms	1-Ethyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic Acid Impurity K; Norfloxacin Related Compound K; 7-[(2-Aminoethyl)amino]-1-ethyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid; Norfloxacin Impurity K (EP); Norfloxacin Process Impurity; 1-Ethyl-6-fluoro-7-(2-aminoethylamino)-4-oxoquinoline-3-carboxylic Acid; Norfloxacin Derivative K
EINECS	Contact for details

Quality Control

Every batch of Norfloxacin EP Impurity K is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

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