Description

Enrofloxacin Ep Impurity C is a high-purity reference standard used for analytical and quality control purposes in the pharmaceutical industry. This compound is critical for ensuring the safety and efficacy of veterinary and human pharmaceutical products by accurately identifying and quantifying related substances. It is an essential material for research and development laboratories, quality assurance departments, and regulatory bodies focused on fluoroquinolone antibiotics. Precise characterization of such impurities is fundamental to meeting stringent pharmacopoeial standards for drug substances and finished products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Enrofloxacin-related impurities in compliance with EP, USP, and other pharmacopoeias.
• Method Development and Validation: Crucial for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and LC-MS/MS assays.
• Quality Control (QC) Testing: Used in the routine QC testing of Enrofloxacin Active Pharmaceutical Ingredient (API) and its formulated drug products to monitor impurity profiles.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to track the formation of specific degradation products.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing definitive impurity characterization data.
• Research on Degradation Pathways: Facilitates research into the chemical stability and degradation mechanisms of fluoroquinolone antibiotics.

Basic Information

Product Name	Enrofloxacin Ep Impurity C
CAS No.	138892-82-7
Molecular Formula	C19H22FN3O3
Molecular Weight	359.40 g/mol
Synonyms	1-Cyclopropyl-7-(4-ethylpiperazin-1-yl)-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid; Enrofloxacin Impurity C; Enrofloxacin Related Compound C; 4-Oxo-Enrofloxacin; Baytril Impurity C; 1,4-Dihydro-4-oxo-1-cyclopropyl-6-fluoro-7-(4-ethyl-1-piperazinyl)-3-quinolinecarboxylic Acid; ENRO-C
EINECS	Contact for details

Quality Control

Every batch of Enrofloxacin Ep Impurity C is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopoeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting your regulatory and quality assurance requirements.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

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%
Residue on Ignition	≤ 0.2%

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