Description

Norfloxacin EP Impurity E is a high-purity reference standard critical for the analytical profiling and quality control of the antibiotic Norfloxacin. This compound is essential for pharmaceutical manufacturers and quality control laboratories to identify, quantify, and monitor this specific impurity during drug development and production, ensuring final product safety and compliance with stringent pharmacopeial standards. It is primarily used in research, method validation, and regulatory filing for generic and innovator pharmaceutical products.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Norfloxacin EP Impurity E in active pharmaceutical ingredient (API) and finished drug product testing.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity profiling of Norfloxacin.
• Quality Control & Assurance (QC/QA): Critical for routine batch release testing to ensure Norfloxacin API and formulations meet European Pharmacopoeia (EP), United States Pharmacopeia (USP), or ICH guidelines for impurity limits.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., ANDA, DMF) by providing necessary impurity characterization data for health authorities like the FDA and EMA.
• Stability Studies: Employed to monitor the formation of this degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability testing programs.
• Research & Development: Used in chemical research to study the degradation pathways, synthesis impurities, and metabolism of Norfloxacin and related fluoroquinolone antibiotics.

Basic Information

Product Name	Norfloxacin EP Impurity E
CAS No.	75001-78-4
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 Ethyl Ester; Norfloxacin Ethyl Ester; Norfloxacin Impurity E; Norfloxacin Related Compound E; 1-Ethyl-6-fluoro-7-(piperazin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid Ethyl Ester; Ethyl 1-ethyl-6-fluoro-4-oxo-7-(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylate; Norfloxacin Ester Impurity
EINECS	Contact for details

Quality Control

Every batch of Norfloxacin EP Impurity E is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques like HPLC and LC-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, and residual solvents.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive (store away from light).

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 unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
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.