Description

Norfloxacin Imp.(Ep) CAS NO 1911573-08-4 is a high-purity chemical reference standard, specifically an impurity of the fluoroquinolone antibiotic Norfloxacin, as defined by the European Pharmacopoeia (EP). This compound is critical for analytical method development, validation, and quality control processes in pharmaceutical manufacturing. It is primarily used by research institutions, quality assurance laboratories, and API producers to ensure the safety, efficacy, and regulatory compliance of Norfloxacin-based drug products.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for identifying and quantifying this specific impurity in Norfloxacin Active Pharmaceutical Ingredient (API) and finished drug formulations.
• Analytical Method Development & Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, or other chromatographic methods for purity analysis.
• Quality Control & Release Testing: Essential for routine batch testing in QC laboratories to ensure Norfloxacin products meet stringent pharmacopoeial specifications (EP, USP, etc.) for impurity limits.
• Stability Studies: Employed in forced degradation and shelf-life studies to monitor the formation of this impurity over time under various stress conditions.
• Regulatory Compliance & Documentation: Provides the necessary reference data for regulatory filings (e.g., CMC sections for FDA, EMA) to demonstrate thorough impurity control.
• Research on Degradation Pathways: Aids academic and industrial researchers in studying the synthesis and degradation mechanisms of fluoroquinolone antibiotics.

Basic Information

Product Name	Norfloxacin Imp.(Ep)
CAS No.	1911573-08-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Norfloxacin EP Impurity; Norfloxacin Related Compound; Norfloxacin Impurity Standard; 1-Ethyl-6-fluoro-4-oxo-7-(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylic acid impurity; Fluoroquinolone Impurity; Antibiotic Impurity Standard; Pharmaceutical Reference Standard
EINECS	Contact for details

Quality Control

Every batch of Norfloxacin Imp.(Ep) CAS 1911573-08-4 is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including advanced chromatographic techniques, to confirm identity and purity in compliance with pharmacopoeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results for identity, assay, purity, and related substances is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Meets EP requirements
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%

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