Description

Enrofloxacin Ep Impurity E is a high-purity reference standard critical for the analytical profiling and quality control of the veterinary fluoroquinolone antibiotic, Enrofloxacin. This compound serves as a specified impurity, essential for pharmaceutical manufacturers and testing laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily used by professionals in pharmaceutical R&D, quality assurance, and regulatory affairs for method development, validation, and batch release testing.

Application

• Primary use as a certified reference standard for the identification and quantification of Enrofloxacin EP Impurity E in active pharmaceutical ingredients (APIs) and finished drug products.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) for veterinary pharmaceutical quality control.
• Used in stability studies and forced degradation studies to monitor impurity profiles and establish shelf-life.
• Essential for regulatory submissions (e.g., CMC sections for FDA, EMA, ICH guidelines) to demonstrate thorough impurity characterization.
• Supports pharmacopoeial testing to meet standards set by EP, USP, or other international pharmacopoeias.
• Valuable for academic and industrial research into the degradation pathways and metabolism of fluoroquinolone antibiotics.

Basic Information

Product Name	Enrofloxacin Ep Impurity E
CAS No.	1369495-59-9
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 Ethylpiperazine Impurity; Enrofloxacin Impurity E (EP); Enrofloxacin Related Compound E; 1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic Acid Ethyl Derivative; BAQ 805A; Baytril Impurity E
EINECS	Contact for details

Quality Control

Every batch of Enrofloxacin Ep Impurity E is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques to ensure compliance with pharmacopoeial 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) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	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.