Description

Marbofloxacin Ep Impurity D is a high-purity reference standard used in the pharmaceutical development and quality control of the veterinary fluoroquinolone antibiotic, Marbofloxacin. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient by serving as a key marker for impurity profiling and analytical method validation. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing, particularly for companies producing or regulating veterinary medicines.

Application

This certified reference material is primarily utilized in analytical and regulatory settings to guarantee product quality and compliance.

• Pharmaceutical Reference Standard: Serves as a primary standard for the identification and quantification of Marbofloxacin Ep Impurity D in drug substances and products.
• Analytical Method Development and Validation (HPLC/LC-MS): Used to develop, calibrate, and validate chromatographic methods for impurity detection.
• Quality Control and Batch Release Testing: Employed in routine QC labs to monitor impurity levels against established pharmacopeial specifications (e.g., EP, USP).
• Stability Studies: Acts as a benchmark to track the formation of this specific degradation product under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMF), investigational new drug (IND) applications, and marketing authorization dossiers.
• Research and Development: Used in studies to understand the degradation pathways and chemistry of Marbofloxacin.

Basic Information

Product Name	Marbofloxacin Ep Impurity D
CAS No.	117380-92-4
Molecular Formula	C₁₇H₁₉F₂N₃O₄
Molecular Weight	367.35 g/mol
Synonyms	1-Cyclopropyl-6-fluoro-7-[(3aS,7aS)-octahydro-1H-pyrrolo[3,4-b]pyridin-6(2H)-yl]-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid; Marbofloxacin Impurity D; Marbofloxacin European Pharmacopoeia Impurity D; 1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl)-4-oxo-3-quinolinecarboxylic acid
EINECS	Contact for details

Quality Control

Our Marbofloxacin Ep Impurity D is manufactured and controlled to meet the exacting standards required for pharmaceutical reference materials. Each batch undergoes rigorous analytical testing, including HPLC for purity and spectroscopic confirmation (NMR, MS) for structural identity. A comprehensive Certificate of Analysis (COA) is supplied, detailing batch-specific results and confirming compliance with in-house specifications aligned with pharmacopeial 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 must be kept under anhydrous conditions to maintain stability and purity.

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)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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