Description

Moxifloxacin Related Compound F (25 mg) (1-Cyclopropyl-6-fluoro-8-methoxy-7-(1-methyloctahydro-6H-pyrrolo[3,4-b]pyridin-6-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid) is a high-purity reference standard critical for analytical and quality control processes in the pharmaceutical industry. This compound serves as a specified impurity and degradation product of the broad-spectrum fluoroquinolone antibiotic, Moxifloxacin, enabling precise monitoring and control of drug substance and product quality. It is an essential material for research laboratories, analytical service providers, and pharmaceutical manufacturers engaged in method development, validation, and regulatory compliance for Moxifloxacin-based therapeutics.

Application

• Pharmaceutical Impurity Profiling and Control: Used as a certified reference standard for the identification and quantification of Related Compound F in Moxifloxacin Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to separate and analyze Moxifloxacin and its related substances.
• Stability Studies and Forced Degradation Testing: Employed to identify and track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity, acid/base hydrolysis).
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submissions (e.g., for FDA, EMA) by providing a characterized impurity standard for specification setting and quality assurance.
• Quality Control (QC) Laboratory Testing: Serves as a primary standard in routine QC release testing of Moxifloxacin batches to ensure compliance with pharmacopeial limits (e.g., USP, EP).
• Research on Degradation Pathways: Aids in studying the chemical degradation mechanisms of Moxifloxacin to improve formulation stability and shelf-life.
• Calibration of Analytical Instruments: Used to calibrate and ensure the accuracy of UV detectors, mass spectrometers, and other analytical equipment in pharmaceutical analysis.

Basic Information

Item	Details
Product Name	Moxifloxacin Related Compound F (25 mg)
CAS No.	1179992-99-4
Molecular Formula	C24H28FN3O4
Molecular Weight	441.50 g/mol
Synonyms	1-Cyclopropyl-6-fluoro-8-methoxy-7-(1-methyloctahydro-6H-pyrrolo[3,4-b]pyridin-6-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid; Moxifloxacin Impurity F; Moxifloxacin Related Substance F; Avelox Related Compound F; 7-[(4aS,7aS)-1-Methyloctahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-1-cyclopropyl-6-fluoro-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid; BAY 12-8039 Impurity F; Moxifloxacin EP Impurity F
EINECS	Contact for details

Quality Control

Our Moxifloxacin Related Compound F is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced techniques such as HPLC, NMR, and MS. Our quality system is designed to support pharmaceutical research and regulatory compliance, with specifications aligned to the requirements of major pharmacopeias. Certificates of Analysis are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccant use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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