Description

Norfloxacin Impurity CAS NO 54132-24-0 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Norfloxacin. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. Utilizing this well-characterized impurity standard is essential for maintaining stringent quality control in the production of fluoroquinolone antibiotics.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for identifying and quantifying related substances in Norfloxacin API and finished drug products.
• Analytical Method Development and Validation: Used as a system suitability standard to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for purity analysis.
• Quality Control and Assurance (QC/QA): Acts as a critical benchmark in routine quality control testing to ensure Norfloxacin batches meet pharmacopeial specifications (e.g., USP, EP, BP).
• Stability Studies: Employed to monitor the formation of degradation products in Norfloxacin under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance and Submissions: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research and Development: Used in R&D laboratories to study the synthesis pathways, degradation mechanisms, and metabolic pathways of Norfloxacin.
• Calibration Standard: Functions as a precise calibration standard for spectroscopic and chromatographic instruments.

Basic Information

Product Name	Norfloxacin Impurity
CAS No.	54132-24-0
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; Norfloxacin Related Compound; 1-Ethyl-6-fluoro-7-(piperazin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid Impurity; Norfloxacin EP Impurity; Norfloxacin USP Impurity; 7-(1-Piperazinyl)-1-ethyl-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic Acid Impurity; Noroxin Impurity
EINECS	Contact for details

Quality Control

Every batch of Norfloxacin Impurity (CAS 54132-24-0) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere at -20°C to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 0.5% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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