Description

Moxifloxacin Impurity 56 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 well-characterized impurities like this is essential for meeting stringent pharmacopeial standards.

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: 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 to monitor impurity profiles and understand degradation pathways of Moxifloxacin.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Research & Development: Used in R&D laboratories to study the synthesis, metabolism, and toxicity profile of Moxifloxacin-related compounds.
• Pharmacopeial Testing: Serves as a system suitability standard for tests prescribed in pharmacopeias like USP, EP, or BP for Moxifloxacin monographs.

Basic Information

Product Name	Moxifloxacin Impurity 56
CAS No.	1928753-99-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Moxifloxacin Related Compound 56; Moxifloxacin EP Impurity J; Moxifloxacin USP Impurity; 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; (1S,6S)-7-(6-Fluoro-8-methoxy-1-cyclopropyl-4-oxo-1,4-dihydroquinolin-3-yl)-4,7-diazaspiro[bicyclo[4.2.0]octane-2,1'-cyclopropane]-8-one; Avelox Impurity 56; Moxifloxacin Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Moxifloxacin Impurity 56 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with cGMP, ICH Q3A/B, and relevant USP/EP guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unknown impurity ≤ 0.5%; Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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