Description

Ciprofloxacin Impurity 19 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the antibiotic ciprofloxacin. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product through accurate analytical method development and validation. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing, particularly for those working on fluoroquinolone antibiotics.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in ciprofloxacin Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development: Crucial for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance: Used in routine batch testing to ensure ciprofloxacin batches meet stringent pharmacopeial (e.g., USP, EP, BP) specifications for impurity limits.
• Stability Studies: Employed to identify and track degradation products that may form during the shelf-life studies of ciprofloxacin formulations.
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing characterized impurity data required for drug approval.
• Process Chemistry Research: Aids in understanding the synthesis pathway of ciprofloxacin, helping to optimize manufacturing processes to minimize this specific impurity.

Basic Information

Item	Details
Product Name	Ciprofloxacin Impurity 19
CAS No.	110600-99-2
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 Related Compound; Ciprofloxacin EP Impurity; Ciprofloxacin USP Impurity; Fluoroquinolone Impurity; 7-(1-Piperazinyl)-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid; 1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid
EINECS	Contact for details

Quality Control

Every batch of Ciprofloxacin Impurity 19 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC and LC-MS to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept in a desiccated environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residue on Ignition	≤ 0.5%

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