Description

Moxifloxacin Impurity 51 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 stringent pharmacopeial standards in antibiotic production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Moxifloxacin Impurity 51 in drug substances and finished products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles in Moxifloxacin API.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure impurity levels are within International Conference on Harmonisation (ICH) and pharmacopeial limits (USP, EP).
• Stability Studies: Used to track the formation and growth of this specific impurity during forced degradation and long-term stability studies of Moxifloxacin formulations.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Common Technical Documents (CTD), and other regulatory filings to health authorities like the FDA and EMA.
• Research & Development: Serves as a key intermediate or degradation product for studying the synthesis pathway, metabolism, and degradation mechanisms of Moxifloxacin.

Basic Information

Product Name	Moxifloxacin Impurity 51
CAS No.	2272024-58-3
Molecular Formula	C21H24FN3O4
Molecular Weight	401.43 g/mol
Synonyms	1-Cyclopropyl-7-[(2S,4S)-2-fluoro-4-(hydroxymethyl)-1-pyrrolidinyl]-6,8-difluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic Acid Impurity; Moxifloxacin Related Compound 51; Moxifloxacin EP Impurity J; Moxifloxacin USP Impurity; Avelox Impurity 51; 7-[(4S)-2,8-Diazabicyclo[4.3.0]non-8-yl]-1-cyclopropyl-6-fluoro-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid Derivative; Moxifloxacin Degradation Product
EINECS	Contact for details

Quality Control

Every batch of Moxifloxacin Impurity 51 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling 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 for purity, related substances, residual solvents, and other critical parameters. We support compliance with ICH Q3A, Q3B, USP, and EP 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 powder
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

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