Description

Ciprofloxacin Ep Impurity E is a high-purity reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the widely used antibiotic, Ciprofloxacin. It is primarily required by pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and regulatory affairs teams for method validation, impurity profiling, and batch release testing.

Application

• Primary use as a certified reference standard for the identification and quantification of Ciprofloxacin EP Impurity E in active pharmaceutical ingredient (API) and finished drug product analysis.
• Essential for pharmaceutical research and development, supporting method development and validation studies for impurity control strategies.
• Critical component in quality control (QC) laboratories for routine batch testing to ensure compliance with pharmacopoeial specifications (e.g., EP, USP).
• Used in stability studies to monitor the formation of degradation products in Ciprofloxacin formulations over time.
• Supports regulatory submissions (e.g., ANDA, NDA) by providing definitive impurity characterization data required by agencies like the FDA and EMA.
• Valuable for academic and institutional research focusing on the synthesis, degradation pathways, and analytical profiling of fluoroquinolone antibiotics.

Basic Information

Product Name	Ciprofloxacin Ep Impurity E
CAS No.	879005-96-6
Molecular Formula	C17H18FN3O3
Molecular Weight	331.34 g/mol
Synonyms	1-Cyclopropyl-6-fluoro-7-(piperazin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid (Ethylenediamine Adduct); Ciprofloxacin Ethylenediamine Salt; Ciprofloxacin Impurity E (EP); Ciprofloxacin Compound with 1,2-ethanediamine (1:1); Ciprofloxacin EDA Adduct; 1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic Acid Compound with 1,2-ethanediamine; Ciprofloxacin EP Impurity E
EINECS	Contact for details

Quality Control

Every batch of Ciprofloxacin EP Impurity E is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and compliance with high-grade reference standard specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with cGMP and relevant pharmacopoeial guidelines (EP/USP) for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.0%

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