Description

Norfloxacin Impurity 1 is a specified impurity of the broad-spectrum fluoroquinolone antibiotic, Norfloxacin. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method validation and quality control processes. It is primarily utilized by analytical chemists, quality assurance professionals, and R&D scientists in the pharmaceutical and contract research organization (CRO) sectors to ensure the purity, safety, and efficacy of Norfloxacin API and its formulations.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of this specific impurity in Norfloxacin Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to separate and accurately measure Norfloxacin and its related substances.
• Quality Control & Batch Release Testing: Employed in routine QC laboratories to monitor impurity profiles and ensure compliance with stringent pharmacopeial limits (e.g., ICH Q3B(R2) guidelines).
• Stability Studies: Used to track the formation of degradation impurities in Norfloxacin under various stress conditions (heat, light, humidity) as part of drug stability testing programs.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings with agencies like the FDA, EMA, and other global health authorities.
• Research on Degradation Pathways: Aids in understanding the chemical degradation mechanisms of Norfloxacin, supporting the development of more stable formulations.

Basic Information

Product Name	Norfloxacin Impurity 1
CAS No.	70032-16-5
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 A; 1-Ethyl-6-fluoro-7-(piperazin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid Impurity; Norfloxacin EP Impurity A; Norfloxacin USP Related Compound A; Noroxin Impurity; 7-(1-Piperazinyl)-1-ethyl-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic Acid Impurity
EINECS	Contact for details

Quality Control

Our Norfloxacin Impurity 1 is manufactured under strict quality systems suitable for use as a reference standard. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, GC, NMR, and MS to confirm identity and purity. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. The material is suitable for use in methods aligned with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent absorption of water vapor.

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%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm
Single Unknown Impurity (HPLC)	≤ 1.0%
Total Impurities (HPLC)	≤ 5.0%

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