Description

Moxifloxacin Impurity 69 CAS NO 1430075-08-3 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 required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

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: Serves as a critical standard for developing and validating HPLC, UPLC, and other chromatographic methods in quality control laboratories.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Stability Studies: Employed to monitor the formation of degradation products in Moxifloxacin formulations under various stress conditions.
• Research & Development: Used in R&D settings to study the degradation pathways, synthesis impurities, and metabolic byproducts of Moxifloxacin.
• Quality Assurance/Quality Control (QA/QC): Acts as a system suitability standard and for routine batch release testing to ensure product purity meets pharmacopeial specifications.

Basic Information

Product Name	Moxifloxacin Impurity 69
CAS No.	1430075-08-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	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; Moxifloxacin Related Compound; Moxifloxacin EP Impurity; Moxifloxacin USP Impurity; Moxifloxacin Degradant; Avelox Impurity; BAY 12-8039 Impurity
EINECS	Contact for details

Quality Control

Every batch of Moxifloxacin Impurity 69 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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 desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to Off-white powder
Identification (HPLC)	Conforms
Identification (IR)	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%

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