Description

Moxifloxacin Impurity 80 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) Moxifloxacin. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, stability studies, and impurity profiling. The reliable identification and quantification of this impurity are fundamental to meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Moxifloxacin API and finished drug products.
• Analytical Method Development and Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control and Assurance (QC/QA): Used in routine batch testing within pharmaceutical QC laboratories to monitor impurity levels against established specifications.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control strategies.
• Research and Development: Supports impurity isolation, characterization, and toxicological studies during the drug development lifecycle.

Basic Information

Product Name	Moxifloxacin Impurity 80
CAS No.	2331091-31-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Moxifloxacin Related Compound 80; Moxifloxacin EP Impurity I; Moxifloxacin USP Impurity; 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 impurity; Avelox Impurity; Moxifloxacin Process Impurity; Moxifloxacin Degradant
EINECS	Contact for details

Quality Control

Every batch of Moxifloxacin Impurity 80 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards (e.g., USP, EP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability information.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under inert atmosphere to prevent potential degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
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.