Description

Marbofloxacin Ep Impurity A is a high-purity reference standard used in the analytical profiling and quality control of the veterinary fluoroquinolone antibiotic, Marbofloxacin. This compound is critical for pharmaceutical manufacturers and testing laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is an essential material for research and development, method validation, and stability studies within the veterinary pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Marbofloxacin Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Crucial for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Stability Studies & Forced Degradation: Used to monitor the formation of degradation products under various stress conditions (e.g., heat, light, humidity) to establish shelf-life and storage conditions.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity profiling data required for drug master files (DMFs) and marketing authorization applications.
• Quality Control Testing: Enables routine batch release testing of Marbofloxacin to ensure it meets pharmacopeial specifications (e.g., EP, USP) for impurity limits.
• Research on Degradation Pathways: Serves as a key marker in studies investigating the chemical stability and degradation mechanisms of Marbofloxacin.

Basic Information

Product Name	Marbofloxacin Ep Impurity A
CAS No.	115551-40-1
Molecular Formula	C₁₇H₁₉F₂N₃O₄
Molecular Weight	367.35 g/mol
Synonyms	1-Cyclopropyl-6-fluoro-7-[(2S,6S)-2,6-dimethyl-4-(methylamino)piperidin-1-yl]-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid; Marbofloxacin Impurity A; Marbofloxacin Related Compound A; 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; (S,S)-Marbofloxacin Impurity A; Marbofloxacin EP Impurity A
EINECS	Contact for details

Quality Control

Every batch of Marbofloxacin Ep Impurity A is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques (HPLC, LC-MS, NMR) to ensure it meets the stringent requirements for use as a reference standard. A detailed Certificate of Analysis (COA) providing batch-specific data is supplied with each product.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption, which could affect 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)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.