Description

Moxifloxacin Related Impurity 2 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development. This compound is critical for ensuring the safety and efficacy of the antibiotic moxifloxacin by enabling the accurate identification and quantification of process-related impurities. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the qualitative and quantitative analysis of moxifloxacin and its related substances.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Assurance (QC/QA): Essential for in-process testing and final release testing of moxifloxacin active pharmaceutical ingredients (APIs) and finished drug products to meet pharmacopeial standards (USP, EP).
• Stability Studies: Employed as a marker to monitor impurity formation and degradation pathways in moxifloxacin formulations under various storage conditions.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity data for safety assessments and specification justifications.
• Research & Development (R&D): Used in synthetic chemistry research to study impurity formation mechanisms and to develop purification processes.

Basic Information

Product Name	Moxifloxacin Related Impurity 2
CAS No.	169533-56-6
Molecular Formula	C21H24FN3O4
Molecular Weight	401.43 g/mol
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 Impurity 2; Moxifloxacin EP Impurity B; Moxifloxacin USP Related Compound B; Avelox Impurity 2; BAY 12-8039 Impurity 2
EINECS	Contact for details

Quality Control

Every batch of Moxifloxacin Related Impurity 2 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity analysis and spectroscopic identification, to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and 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 should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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