Description

Ciprofloxacin Ep Impurity B 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 active pharmaceutical ingredient (API) ciprofloxacin, a widely used fluoroquinolone antibiotic. It is an essential tool for researchers and quality assurance professionals in pharmaceutical companies, contract research organizations (CROs), and regulatory testing laboratories who require precise impurity profiling and method validation.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of a specified impurity in ciprofloxacin API and finished drug products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity detection.
• Quality Control and Release Testing: Employed in routine QC laboratories to monitor impurity levels against strict pharmacopeial limits (e.g., EP, USP, ICH guidelines) to ensure batch-to-batch consistency.
• Stability Studies: Utilized to track the formation of this specific degradation product under various stress conditions, supporting drug shelf-life determination.
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Aids in synthetic route optimization and process chemistry by helping to understand and control impurity formation during API synthesis.

Basic Information

Product Name	Ciprofloxacin Ep Impurity B
CAS No.	93107-11-0
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 B (EP); Ciprofloxacin Related Compound B; 7-[(3-Amino-1-pyrrolidinyl)methyl]-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic Acid; Ciprofloxacin Process Impurity; Quinolone Carboxylic Acid Derivative
EINECS	Contact for details

Quality Control

Every batch of Ciprofloxacin Ep Impurity B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

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)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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