Description

Moxifloxacin Acyl-B-D-Glucuronide is a crucial metabolite and reference standard of the broad-spectrum fluoroquinolone antibiotic, moxifloxacin. This high-purity compound is essential for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics, and bioanalytical method validation. It is primarily utilized by analytical laboratories, contract research organizations (CROs), and pharmaceutical companies engaged in drug discovery and regulatory compliance activities.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the quantitative and qualitative analysis of moxifloxacin and its metabolites in biological matrices.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Used to investigate the metabolic pathways, clearance mechanisms, and pharmacokinetic profile of moxifloxacin.
• Bioanalytical Method Development: Critical for developing and validating robust HPLC, LC-MS, or LC-MS/MS methods for therapeutic drug monitoring and clinical studies.
• Impurity Profiling and Characterization: Employed to identify, quantify, and qualify process-related impurities or degradation products in moxifloxacin API and finished dosage forms.
• Regulatory Submissions: Provides essential data to support regulatory filings (e.g., with the FDA, EMA) by characterizing the drug's metabolic fate.
• Toxicology and Safety Assessment: Aids in understanding the safety profile and potential toxicity of moxifloxacin metabolites.

Basic Information

Product Name	Moxifloxacin Acyl-B-D-Glucuronide
CAS No.	733002-61-4
Molecular Formula	C30H33FN4O12
Molecular Weight	636.60 g/mol
Synonyms	Moxifloxacin Acyl-β-D-Glucuronide; Moxifloxacin Glucuronide; 1-Cyclopropyl-6-fluoro-8-methoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-1,4-dihydroquinoline-3-carboxylic acid β-D-glucopyranosiduronic acid ester; Avelox Glucuronide; BAY 12-8039 Glucuronide
EINECS	Contact for details

Quality Control

Our Moxifloxacin Acyl-B-D-Glucuronide is manufactured under strict quality control protocols to ensure the highest standards of purity and consistency, suitable for use as a reference standard. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results from advanced analytical techniques including HPLC, LC-MS, and NMR for structural confirmation. We adhere to relevant industry guidelines to support our clients' regulatory and research needs.

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 product 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)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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