Description

Ciprofloxacin EP Impurity B HCl is a high-purity chemical 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 antibiotic Ciprofloxacin by accurately identifying and quantifying this specific impurity. It is an essential material for analytical chemists and quality assurance professionals working in pharmaceutical R&D, quality control laboratories, and regulatory affairs.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of Ciprofloxacin EP Impurity B in active pharmaceutical ingredients (APIs) and finished drug products.
• Method development and validation for impurity profiling in compliance with pharmacopoeial standards (e.g., European Pharmacopoeia, USP).
• Calibration of analytical instruments such as High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS) systems.
• Stability studies and forced degradation studies to understand the degradation pathways of Ciprofloxacin.
• Quality control batch release testing to ensure impurity levels are within specified safety limits.
• Research and development of generic Ciprofloxacin formulations.
• Training and educational purposes within analytical chemistry and pharmaceutical science.

Basic Information

Product Name	Ciprofloxacin EP Impurity B HCl
CAS No.	2727369-47-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1-Cyclopropyl-6-fluoro-7-chloro-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid Hydrochloride; Ciprofloxacin Impurity B HCl; Ciprofloxacin Related Compound B Hydrochloride; 7-Chloro-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid Hydrochloride; Fluoroquinolone Impurity; Cipro Impurity B HCl
EINECS	Contact for details

Quality Control

Every batch of Ciprofloxacin EP Impurity B HCl is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity confirmation and spectroscopic methods for structural verification, to ensure compliance with pharmaceutical reference standard requirements. Comprehensive Certificates of Analysis (COA) detailing batch-specific results are provided and available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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 structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Water Content	≤ 5.0%
Residue on Ignition	≤ 0.5%

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