Description

Moxifloxacin Impurity 52 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 quality control testing. The availability of this well-characterized impurity standard is essential for maintaining the integrity of the pharmaceutical supply chain.

Application

• Pharmaceutical Quality Control (QC): Used as a certified reference standard for the identification and quantification of impurities in Moxifloxacin API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or other chromatographic methods for impurity profiling.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to monitor the formation and levels of this specific impurity during forced degradation and long-term stability testing of Moxifloxacin formulations.
• Research & Development (R&D): Serves as a key intermediate or marker in synthetic chemistry research and the study of Moxifloxacin degradation pathways.
• Pharmacopoeial Standards: Can be utilized to support testing against specifications outlined in pharmacopoeias such as USP, EP, or BP.

Basic Information

Product Name	Moxifloxacin Impurity 52
CAS No.	41928-40-9
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 Related Compound 52; Moxifloxacin EP Impurity G; Moxifloxacin USP Impurity; Avelox Impurity 52; BAY 12-8039 Impurity; (1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro-1H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxoquinoline-3-carboxylic acid)
EINECS	Contact for details

Quality Control

Our Moxifloxacin Impurity 52 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, MS, NMR), to ensure compliance with high-grade reference standard specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided to support your quality and regulatory requirements.

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 maintain stability and purity. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single 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.