Description

N‐Nitrosonorfloxacin CAS NO 74011-53-3 is a specific nitrosated derivative of the fluoroquinolone antibiotic norfloxacin. This compound is of significant interest in pharmaceutical research and development, particularly in the study of nitrosamine impurities, which are a critical focus for regulatory compliance and drug safety. It serves as a vital reference standard and impurity marker for analytical laboratories, research institutions, and pharmaceutical manufacturers engaged in quality control, method development, and stability testing of quinolone-based APIs and finished drug products.

Application

• Primary use as a certified reference standard (CRS) for the identification and quantification of nitrosamine impurities.
• Critical component in analytical method development and validation for pharmaceutical quality control laboratories.
• Essential material for stability and forced degradation studies of norfloxacin and related fluoroquinolone drugs.
• Used in regulatory compliance testing to meet stringent guidelines from agencies like the FDA and EMA regarding nitrosamine risk assessment.
• Valuable research chemical for investigating the formation, fate, and toxicity of nitrosated drug derivatives.
• Supplies to contract research organizations (CROs) and academic institutions conducting pharmaceutical safety research.

Basic Information

Product Name	N‐Nitrosonorfloxacin
CAS No.	74011-53-3
Molecular Formula	C16H17FN4O4
Molecular Weight	348.33 g/mol
Synonyms	1-Ethyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic Acid, N-Nitroso Derivative; Norfloxacin Nitrosamine; N-Nitroso Norfloxacin; N-Nitrosonorfloxacin Impurity; Nitrosamine Impurity of Norfloxacin; Norfloxacin Related Compound N; NDMA Analog of Norfloxacin
EINECS	Contact for details

Quality Control

Every batch of our N‐Nitrosonorfloxacin is manufactured and controlled to the highest standards for reference materials. We provide comprehensive analytical documentation to support its use in regulated environments. Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) with detailed chromatographic purity, identity confirmation (IR, NMR, MS), and quantitative assay data are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). The compound is light-sensitive (store away from light). For long-term storage under inert atmosphere is recommended to ensure maximum stability.

Specification

Item	Specification
Appearance	Off-white to light yellow powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%

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