Description

Marbofloxacin Ep Impurity B is a high-purity chemical reference standard, specifically identified as a known impurity of the veterinary fluoroquinolone antibiotic Marbofloxacin. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is primarily utilized by research institutions, analytical laboratories, and pharmaceutical companies involved in the development and production of veterinary medicines to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the identification and quantification of impurities in Marbofloxacin Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development: Used in HPLC, UPLC, and LC-MS methods to establish system suitability, specificity, and detection limits for impurity profiling.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in GMP environments to monitor and control impurity levels against ICH guidelines.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and marketing authorization applications.
• Stability Studies: Employed to track the formation of degradation products in Marbofloxacin formulations under various stress conditions.
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Marbofloxacin.

Basic Information

Product Name	Marbofloxacin Ep Impurity B
CAS No.	115551-41-2
Molecular Formula	C₁₇H₁₉FN₄O₄
Molecular Weight	362.36 g/mol
Synonyms	9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[3,2,1-ij][1,4]benzoxazine-6-carboxylic acid; Marbofloxacin Impurity B; Marbofloxacin Related Compound B; 1-Cyclopropyl-6-fluoro-7-[(4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-1,4-dihydroquinoline-3-carboxylic acid (isomer); Marbofloxacin EP Impurity B
EINECS	Contact for details

Quality Control

Every batch of Marbofloxacin Ep Impurity B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards (EP, USP) and ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. 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 corresponds to reference standard
Purity (HPLC, Area %)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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