Description

Norfloxacin EP Impurity C is a specified impurity reference standard used in the analytical profiling and 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 routine testing within the pharmaceutical quality assurance and regulatory sectors.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Norfloxacin EP Impurity C in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or other chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor and control impurity levels, ensuring compliance with EP, USP, ICH, and other regulatory guidelines.
• Stability Studies: Employed as a marker to track impurity formation and degradation pathways in Norfloxacin under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in synthetic chemistry research to study the formation, isolation, and characterization of process-related impurities.

Basic Information

Product Name	Norfloxacin EP Impurity C
CAS No.	177554-64-2
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 C; Norfloxacin Impurity C; 1-Ethyl-6-fluoro-7-(piperazin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid Impurity; Norfloxacin Related Compound C; Norfloxacin European Pharmacopoeia Impurity C; 7-(4-Ethylpiperazin-1-yl)-1-ethyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid (Potential isomer/structure); Norfloxacin Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Norfloxacin EP Impurity C is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC, NMR, and MS analyses. We support compliance with ICH Q3A/B, EP, and USP guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C to 25°C (59°F to 77°F). Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert conditions to ensure maximum 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%
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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