Description

Norfloxacin EP Impurity F is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the fluoroquinolone antibiotic Norfloxacin by accurately identifying and quantifying this specific impurity. It is an essential material for analytical chemists and quality assurance professionals working in pharmaceutical R&D, quality control laboratories, and regulatory affairs.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Norfloxacin EP Impurity F in active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development and Validation: Crucial for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Ultra-Performance Liquid Chromatography (UPLC) assays.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity profiles and ensure drug substance and drug product batches meet stringent pharmacopeial specifications (e.g., EP, USP).
• Stability Studies: Employed to track the formation of degradation impurities in Norfloxacin formulations under various stress conditions (e.g., heat, light, humidity) over time.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing definitive impurity characterization data.
• Research and Development: Facilitates impurity profiling during the synthesis process development and optimization of Norfloxacin API manufacturing.

Basic Information

Product Name	Norfloxacin EP Impurity F
CAS No.	67681-86-1
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 F; Norfloxacin Related Compound F; 1-Ethyl-6-fluoro-7-(piperazin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid Ethyl Ester; Norfloxacin Ester Impurity; 7-(1-Piperazinyl)-1-ethyl-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic Acid Ethyl Ester
EINECS	Contact for details

Quality Control

Every batch of Norfloxacin EP Impurity F is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and conformity to in-house specifications aligned with pharmacopeial expectations. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced analytical techniques including HPLC for assay and related substances, IR and MS for identification, and KF for water content.

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 should be handled in a low-humidity environment to prevent degradation. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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