Description

Moxifloxacin Impurity 46 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. The product is supplied with comprehensive analytical data to support stringent quality control protocols.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control and release testing of Moxifloxacin API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to accurately identify and quantify this specific impurity.
• Stability Studies: Employed in forced degradation and long-term stability studies of Moxifloxacin to monitor impurity formation over time and under various stress conditions.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing a characterized impurity for identification and qualification in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Research & Development: Used in R&D to study the degradation pathways, synthesis impurities, and metabolic profiles related to Moxifloxacin.
• Pharmacopoeial Testing: Serves as a reference material for testing against pharmacopoeial monographs (e.g., USP, EP, BP) that specify limits for known and unknown impurities.

Basic Information

Product Name	Moxifloxacin Impurity 46
CAS No.	1003857-74-6
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 EP Impurity G; Moxifloxacin Related Compound G; Avelox Impurity; BAY 12-8039 Impurity; (4aS,7aS)-7-[(1-Cyclopropyl-6-fluoro-8-methoxy-4-oxo-1,4-dihydroquinolin-3-yl)carbonyl]hexahydro-1H-pyrrolo[3,4-b]pyridin-6(2H)-one
EINECS	Contact for details

Quality Control

Every batch of Moxifloxacin Impurity 46 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC, NMR, MS, and other orthogonal analytical techniques. We support compliance with cGMP, ICH, and relevant pharmacopoeial guidelines.

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 material 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 solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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