Description

Norfloxacin Impurity 2 is a specified impurity and degradation product of the broad-spectrum fluoroquinolone antibiotic, Norfloxacin. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method validation, quality control, and regulatory compliance. It is essential for laboratories in the pharmaceutical industry, contract research organizations (CROs), and regulatory bodies focused on ensuring drug purity, safety, and efficacy.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Norfloxacin impurities in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Critical for developing, calibrating, and validating chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure Norfloxacin API and formulations meet pharmacopeial (e.g., USP, EP, JP) and ICH Q3A/B guidelines for impurities.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of drug stability testing.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research on Degradation Pathways: Facilitates studies into the chemical stability and degradation mechanisms of Norfloxacin.

Basic Information

Product Name	Norfloxacin Impurity 2
CAS No.	75001-63-7
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 2; Norfloxacin Related Compound 2; 7-(4-Ethyl-1-piperazinyl)-6-fluoro-1,4-dihydro-4-oxo-1-ethyl-3-quinolinecarboxylic Acid; Norfloxacin EP Impurity B; Norfloxacin USP Related Compound B; 1-Ethyl-6-fluoro-7-(4-ethylpiperazin-1-yl)-4-oxoquinoline-3-carboxylic acid; Desfluoro Norfloxacin (common misnomer, verify structure).
EINECS	Contact for details

Quality Control

Every batch of Norfloxacin Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards and customer specifications. 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 in a cool, dry place at a 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 (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 ≤ 3.0%
Water Content (KF)	≤ 5.0% w/w
Residue on Ignition	≤ 0.5%

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