Description

Ciprofloxacin Impurity 9 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 tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in method development, validation, and impurity profiling. The precise identification and quantification of this impurity are fundamental to maintaining drug efficacy and patient safety.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in ciprofloxacin API and finished drug products.
• Analytical Method Development: Serves as a critical component in developing and validating HPLC, UPLC, and LC-MS methods for impurity analysis.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency in pharmaceutical manufacturing.
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization reports.
• Stability Studies: Used to track the formation of degradation products in ciprofloxacin formulations under various stress conditions.
• Research & Development: Aids in studying the degradation pathways and metabolism of ciprofloxacin in pharmaceutical research.

Basic Information

Product Name	Ciprofloxacin Impurity 9
CAS No.	1620445-09-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1-Cyclopropyl-6-fluoro-7-(piperazin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid impurity 9; Ciprofloxacin Related Compound 9; Ciprofloxacin EP Impurity J; Ciprofloxacin USP Impurity; Fluoroquinolone Impurity; 4-Oxo-quinoline-3-carboxylic acid derivative impurity
EINECS	Contact for details

Quality Control

Every batch of Ciprofloxacin Impurity 9 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B guidelines and can supply materials suitable for use in regulatory filings.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. The material should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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