Description

Norfloxacin-Acyl-β-Glucuronide is a key metabolite and reference standard used in advanced pharmaceutical research and development. This compound is critical for studying the metabolic pathways, pharmacokinetics, and excretion profiles of the fluoroquinolone antibiotic, norfloxacin. It is primarily utilized by analytical laboratories, pharmaceutical companies, and contract research organizations (CROs) engaged in drug metabolism and bioanalytical studies to ensure accurate quantification and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the quantification of norfloxacin metabolites in biological matrices during pharmacokinetic studies.
• Drug Metabolism and Pharmacokinetics (DMPK) Research: Essential for investigating the Phase II conjugation pathway (glucuronidation) of norfloxacin, aiding in understanding drug clearance mechanisms.
• Bioanalytical Method Development and Validation: Used as a critical calibrator and quality control sample in developing and validating LC-MS/MS and HPLC methods for clinical and preclinical trials.
• Toxicology and Safety Assessment: Employed in studies to assess the safety profile and potential toxicity of norfloxacin metabolites.
• Regulatory Submission Support: Provides essential data for regulatory filings (e.g., FDA, EMA) by enabling precise metabolite identification and quantification in compliance with ICH guidelines.
• Academic and Institutional Research: Supports fundamental research in medicinal chemistry, pharmacology, and analytical science within universities and research institutes.

Basic Information

Product Name	Norfloxacin-Acyl-β-Glucuronide
CAS No.	1260617-45-5
Molecular Formula	C26H31FN4O10
Molecular Weight	578.55 g/mol
Synonyms	Norfloxacin Acyl Glucuronide; Norfloxacin 1-O-β-Acyl Glucuronide; 1-O-(Norfloxacin-1-yl)-β-D-Glucopyranuronic Acid; Norfloxacin Glucuronide Metabolite; Norfloxacin β-D-Glucuronide; 1-β-O-(1-Ethyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid)-D-Glucuronic Acid; Norfloxacin N-Oxide Glucuronide (related metabolite); NFLX-Acyl-Gluc
EINECS	Contact for details

Quality Control

Our Norfloxacin-Acyl-β-Glucuronide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, LC-MS for identity confirmation, and residual solvent analysis, to ensure it meets the stringent requirements for use as a reference standard. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your research and regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below for long-term stability. For short-term use, the material may be stored at 2-8°C. Allow the vial to equilibrate to room temperature in a desiccator before opening to prevent moisture condensation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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