Description

Norfloxacin Impurity CAS NO 1426313-01-0 is a high-purity chemical reference standard essential for the analytical profiling and quality control of the fluoroquinolone antibiotic, Norfloxacin. This impurity is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily used by professionals in pharmaceutical development, quality assurance (QA), and quality control (QC) for method validation, stability studies, and impurity identification.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Norfloxacin Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity profiles throughout the drug manufacturing process.
• Stability Studies & Forced Degradation: Employed to understand the degradation pathways of Norfloxacin and to qualify degradation products that may form under various stress conditions (e.g., heat, light, humidity).
• Quality Control & Batch Release: Serves as a system suitability standard and for setting impurity acceptance criteria to ensure every batch of Norfloxacin meets stringent pharmacopeial specifications (USP, EP, ICH).
• Regulatory Compliance & Filing: Provides essential data for regulatory submissions (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Research & Development: Used in synthetic chemistry research to study the formation and fate of process-related impurities during Norfloxacin synthesis.

Basic Information

Product Name	Norfloxacin Impurity
CAS No.	1426313-01-0
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; Norfloxacin Specified Impurity; Fluoroquinolone Impurity; Antibiotic Impurity Standard; Norfloxacin Analog
EINECS	Contact for details

Quality Control

Every batch of Norfloxacin Impurity (CAS 1426313-01-0) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques to ensure compliance with pharmacopeial and ICH standards. 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); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
Water Content (KF)	≤ 5.0% w/w

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