Description

Marbofloxacin Ep Impurity F is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and regulatory compliance of the veterinary fluoroquinolone antibiotic, Marbofloxacin. It is primarily required by pharmaceutical R&D laboratories, quality assurance departments, and contract research organizations (CROs) involved in the development and manufacturing of veterinary pharmaceuticals.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Marbofloxacin Ep Impurity F in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling of Marbofloxacin.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and calibration standard in routine quality control testing to monitor impurity levels against pharmacopeial limits (e.g., EP, USP).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., CMC sections for FDA, EMA) by providing definitive characterization data for specified impurities.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific degradation product under various stress conditions.
• Research & Development: Used in synthetic chemistry research to study degradation pathways and to synthesize and characterize related compounds.

Basic Information

Product Name	Marbofloxacin Ep Impurity F
CAS No.	194023-72-8
Molecular Formula	C₁₇H₁₉F₂N₃O₄
Molecular Weight	367.35 g/mol
Synonyms	9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[3,2,1-ij][4,1,2]benzoxadiazine-6-carboxylic Acid; Marbofloxacin Impurity F; Marbofloxacin Related Compound F; Marbofloxacin EP Impurity F; 1-Cyclopropyl-6-fluoro-7-[(2S,6R)-2,6-dimethyl-4-(methylamino)piperazin-1-yl]-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid (Alternative IUPAC); Marbofloxacin Degradant F; Marbofloxacin Process Impurity F
EINECS	Contact for details

Quality Control

Our Marbofloxacin Ep Impurity F is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation, NMR and MS for structural verification, and residual solvent analysis. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, ensuring traceability and compliance with current pharmacopeial expectations for reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. The material is light-sensitive (store away from light).

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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.2%

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