Description

Norfloxacin Impurity 2 is a designated impurity of the broad-spectrum fluoroquinolone antibiotic, Norfloxacin. This high-purity reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is essential for researchers and quality assurance professionals in the pharmaceutical industry who require reliable materials for impurity profiling and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Norfloxacin API and finished dosage forms.
• Analytical Method Development & Validation: Used to establish and validate chromatographic methods (HPLC, UPLC) for impurity detection in compliance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and identification standard in routine quality control testing of Norfloxacin batches.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., DMF, CMC sections) by providing definitive impurity characterization data for health authorities like the FDA and EMA.
• Stability Studies: Employed to monitor the formation of degradation products in Norfloxacin under various stress conditions.
• Research & Development: Used in synthetic chemistry research to study impurity formation pathways and in pharmacokinetic studies.

Basic Information

Product Name	Norfloxacin Impurity 2
CAS No.	67681-88-3
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 2; Norfloxacin Related Compound 2; Norfloxacin EP Impurity B; Norfloxacin USP Related Compound B; 1-Ethyl-6-fluoro-7-(piperazin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid Impurity; Norfloxacin Impurity B (EP); Norfloxacin Impurity (USP)
EINECS	Contact for details

Quality Control

Every batch of Norfloxacin Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and chromatographic testing to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, and identification. We support compliance with ICH Q3A(R2), USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The material is hygroscopic (moisture-sensitive); ensure the container is kept in a dry environment.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Single Unknown Impurity (HPLC)	≤ 1.0%
Total Impurities (HPLC)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C

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