Description

Norfloxacin EP Impurity D is a high-purity reference standard used for the analytical control and qualification of the active pharmaceutical ingredient Norfloxacin. This compound is critical for pharmaceutical manufacturers and quality control laboratories to ensure product safety, efficacy, and compliance with stringent pharmacopeial monographs. It is essential for research, method development, and routine testing in the pharmaceutical and analytical chemistry sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for HPLC, LC-MS, and other chromatographic methods in accordance with European Pharmacopoeia (EP) guidelines.
• Method Development and Validation: Crucial for developing, validating, and transferring analytical methods for Norfloxacin API and finished dosage forms.
• Quality Control and Batch Release: Used in-house by API manufacturers and QC labs to monitor and control impurity profiles during production and for final product release.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity identification and qualification data.
• Stability Studies: Employed to track the formation of degradation impurities in Norfloxacin under various stress conditions over time.
• Academic and Contract Research: Serves as a key reagent in pharmaceutical research, impurity synthesis studies, and analytical services offered by CROs.

Basic Information

Product Name	Norfloxacin EP Impurity D
CAS No.	75001-82-0
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 Ethyl Ester; Norfloxacin Ethyl Ester; Norfloxacin Impurity D (EP); 1-Ethyl-6-fluoro-7-(piperazin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid ethyl ester; Norfloxacin Related Compound D; Norfloxacin Ester Impurity; Quinolone impurity.
EINECS	Contact for details

Quality Control

Every batch of Norfloxacin EP Impurity D is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC and NMR to ensure it meets the exacting standards required for a pharmacopeial impurity reference material. 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). This material is hygroscopic (moisture-sensitive) and should be handled in a dry 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
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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