Description

Moxifloxacin Impurity 40 is a designated chemical reference standard used in the analysis and quality control of the fluoroquinolone antibiotic, Moxifloxacin. This impurity is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product. It is primarily utilized by professionals in pharmaceutical R&D, quality assurance (QA), and regulatory affairs for method development, validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Moxifloxacin active pharmaceutical ingredient (API) and finished dosage forms.
• Method Development & Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Assurance: Used in routine batch testing to confirm that Moxifloxacin API and drug products meet stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Stability Studies: Employed to identify and quantify degradation products that may form under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Filing: A necessary component for regulatory submissions (e.g., to FDA, EMA) to demonstrate comprehensive impurity characterization and control.
• Research on Degradation Pathways: Aids in research to understand the chemical degradation mechanisms of Moxifloxacin.

Basic Information

Product Name	Moxifloxacin Impurity 40
CAS No.	121577-35-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
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 J; Moxifloxacin Related Compound J; Moxifloxacin USP Related Compound J; (1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic acid); Moxifloxacin Impurity J; Moxifloxacin Process Impurity
EINECS	Contact for details

Quality Control

Our Moxifloxacin Impurity 40 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural characterization via spectroscopic methods (e.g., MS, NMR). We provide comprehensive Certificates of Analysis (COA) with each shipment, detailing batch-specific results and confirming identity, purity, and strength. Our standards are suitable for use in compliance with current Good Manufacturing Practice (cGMP) and major pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing desiccated at 2-8°C. Handle the material in accordance with safe laboratory practices to prevent contamination.

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 individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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