Description

Ciprofloxacin Impurity 6 Hemisulfate is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound is essential for the quality control and regulatory compliance of the widely used antibiotic, Ciprofloxacin. It serves as a key impurity marker for analytical method development, validation, and stability studies. Pharmaceutical manufacturers, analytical laboratories, and regulatory bodies require this standard to ensure drug safety, efficacy, and purity.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Ciprofloxacin Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods to monitor impurity profiles.
• Stability Studies & Forced Degradation: Used to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Quality Control & Batch Release: Enables precise impurity profiling to ensure every batch of Ciprofloxacin API meets stringent pharmacopeial specifications (USP, EP, JP).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to agencies like the FDA and EMA.
• Research on Degradation Pathways: Supports research into the chemical stability and metabolic pathways of fluoroquinolone antibiotics.

Basic Information

Product Name	Ciprofloxacin Impurity 6 Hemisulfate
CAS No.	93398-92-6
Molecular Formula	C17H18FN3O3 • ½H2SO4
Molecular Weight	Contact for details
Synonyms	1-Cyclopropyl-6-fluoro-4-oxo-7-(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylic acid hemisulfate; Ciprofloxacin Related Compound 6 Hemisulfate; Ciprofloxacin EP Impurity B Hemisulfate; Ciprofloxacin USP Impurity; 7-(1-Piperazinyl)-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic Acid Hemisulfate; Cipro Impurity 6 Hemisulfate; Fluoroquinolone Impurity Standard
EINECS	Contact for details

Quality Control

Our Ciprofloxacin Impurity 6 Hemisulfate is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, LC-MS, NMR, and IR spectroscopy. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, identity, and impurity profile, supporting compliance with ICH Q3A/B, USP, and EP guidelines.

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 product 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 (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC, Area %)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5%; Total impurities ≤ 2.0%

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