Description

Norfloxacin Impurity CAS NO 1620445-19-3 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Norfloxacin. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of a well-characterized impurity standard is essential for maintaining stringent quality control in antibiotic production.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific impurity during the manufacturing and quality control of Norfloxacin API.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to ensure accurate impurity detection.
• Stability Studies and Forced Degradation: Employed in comparative studies to understand the degradation pathways of Norfloxacin and to establish appropriate shelf-life and storage conditions.
• Regulatory Compliance and Submissions: Essential for preparing documentation required by regulatory agencies (e.g., FDA, EMA, ICH) to demonstrate thorough impurity control and product safety.
• Quality Control and Batch Release Testing: Used as an in-house reference standard in QC laboratories to confirm the purity of Norfloxacin batches against established specifications.
• Research and Development: Supports R&D activities aimed at improving synthetic routes, purification processes, and overall understanding of Norfloxacin's chemical behavior.

Basic Information

Product Name	Norfloxacin Impurity
CAS No.	1620445-19-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Norfloxacin Related Compound; Norfloxacin Process Impurity; Norfloxacin Degradant; 1-Ethyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid impurity; 1-Ethyl-6-fluoro-4-oxo-7-piperazin-1-yl-quinoline-3-carboxylic acid impurity; Norfloxacin Specified Impurity; Quinolinecarboxylic acid derivative impurity
EINECS	Contact for details

Quality Control

Every batch of Norfloxacin Impurity (CAS 1620445-19-3) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC, UPLC) and spectroscopic (MS, NMR) techniques to ensure compliance with pharmacopeial standards (e.g., ICH Q3A/B, USP). 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 a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
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.