Description

Norfloxacin Impurity 1 is a designated impurity standard of the broad-spectrum fluoroquinolone antibiotic, Norfloxacin. This high-purity reference material is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is essential for researchers and quality assurance professionals in the pharmaceutical industry who require precise identification and quantification of impurities to ensure drug safety and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Norfloxacin Impurity 1 in active pharmaceutical ingredient (API) and finished drug product analysis.
• Analytical Method Development & Validation (HPLC/LC-MS): Serves as a critical component for developing, optimizing, and validating chromatographic methods to separate and detect this specific impurity.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity profiles and ensure Norfloxacin API meets pharmacopeial (e.g., USP, EP) and internal specification limits.
• Stability Studies: Employed to track the formation of this impurity over time under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate thorough impurity characterization.
• Research & Development: Facilitates studies on impurity formation pathways, degradation kinetics, and the synthesis of Norfloxacin.

Basic Information

Product Name	Norfloxacin Impurity 1
CAS No.	106847-40-9
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 1; Norfloxacin Related Compound 1; 1-Ethyl-6-fluoro-7-(piperazin-1-yl)quinolin-4(1H)-one-3-carboxylic Acid Impurity; Norfloxacin EP Impurity A; Norfloxacin USP Related Compound A; 7-(1-Piperazinyl)-1-ethyl-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic Acid Impurity; Norfloxacin Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Norfloxacin Impurity 1 is manufactured and controlled under a strict quality management system. The material undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. 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 controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption, which could affect 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)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
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.