Description

Ciprofloxacin Impurity D Hcl is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) ciprofloxacin. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, impurity profiling, and stability studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of Impurity D in ciprofloxacin API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency according to pharmacopeial standards (USP, EP).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions, supporting drug shelf-life determination.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Facilitates studies on the synthesis, characterization, and toxicological assessment of ciprofloxacin-related impurities.

Basic Information

Product Name	Ciprofloxacin Impurity D Hcl
CAS No.	526204-10-4
Molecular Formula	C17H19FN3O3 • HCl
Molecular Weight	385.81 g/mol
Synonyms	1-Cyclopropyl-6-fluoro-7-(piperazin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid hydrochloride; Ciprofloxacin Ethylenediamine Impurity D Hydrochloride; Ciprofloxacin Impurity D (Hydrochloride); 7-[(2-Aminoethyl)amino]-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydro-3-quinolinecarboxylic acid hydrochloride; CPD HCl; Quinolone impurity standard
EINECS	Contact for details

Quality Control

Every batch of Ciprofloxacin Impurity D Hcl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced techniques like HPLC and LC-MS to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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 must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm

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