Description

Moxifloxacin Impurity CAS NO 1395471-18-7 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 primarily needed by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in drug development and quality control. The impurity standard is essential for method validation, stability studies, and impurity profiling to meet stringent pharmacopeial requirements.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Moxifloxacin API and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, calibrating, and validating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation of degradation products in Moxifloxacin under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Compliance and Submissions: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Used in R&D to study the metabolic pathways, degradation mechanisms, and synthesis pathways of Moxifloxacin and related compounds.
• Quality Assurance/Quality Control (QA/QC): Acts as a system suitability standard and for routine batch release testing to ensure API purity and specification compliance.

Basic Information

Product Name	Moxifloxacin Impurity
CAS No.	1395471-18-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Moxifloxacin Related Compound; Moxifloxacin Process Impurity; Moxifloxacin Degradant; 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; Moxifloxacin EP Impurity; Moxifloxacin USP Impurity; Avelox Impurity
EINECS	Contact for details

Quality Control

Our Moxifloxacin Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, related substance analysis, and structural confirmation (e.g., NMR, MS) to ensure identity and purity. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data and results. Our quality standards are designed to support compliance with ICH Q3A/B, USP, and EP guidelines for pharmaceutical impurities.

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 must be kept in a desiccated environment to maintain stability and purity. Avoid prolonged exposure to high humidity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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