Description

Ciprofloxacin Ep Impurity D is a high-purity reference standard used in the analytical profiling of the antibiotic Ciprofloxacin. This compound is critical for pharmaceutical quality control, enabling the accurate identification and quantification of this specific impurity during drug substance and product development. It is an essential material for research and quality assurance laboratories in the pharmaceutical and contract research organization (CRO) sectors to ensure compliance with stringent pharmacopeial monographs.

Application

• Primary use as a certified reference standard (CRS) for analytical method development and validation.
• Identification and quantification of specified impurity D in Ciprofloxacin Active Pharmaceutical Ingredient (API) as per European Pharmacopoeia (EP) and other pharmacopeial standards.
• Calibration of analytical instruments, including High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS) systems.
• Quality control testing for regulatory compliance and batch release in pharmaceutical manufacturing.
• Use in stability studies to monitor impurity profiles in Ciprofloxacin formulations over time.
• Supporting research in the synthesis and degradation pathways of fluoroquinolone antibiotics.

Basic Information

Product Name	Ciprofloxacin Ep Impurity D
CAS No.	133210-96-5
Molecular Formula	C17H18FN3O3
Molecular Weight	331.34 g/mol
Synonyms	1-Cyclopropyl-6-fluoro-4-oxo-7-(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylic Acid; Ciprofloxacin Impurity D; Ciprofloxacin Related Compound D; 7-(1-Piperazinyl)-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic Acid; Ciprofloxacin EP Impurity D; Fluoroquinolone Impurity; Quinolone Carboxylic Acid Derivative
EINECS	Contact for details

Quality Control

Every batch of Ciprofloxacin Ep Impurity D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing to ensure they meet the exacting standards required for use as a pharmaceutical reference material. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC, NMR, and mass spectrometry analyses.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. This material is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.2%

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