Description

Nadifloxacin Impurity 6 (S-Nadifloxacin Sulfate Sodium Salt) is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the accurate identification, quantification, and control of impurities during the manufacturing and quality assurance of the antibacterial agent Nadifloxacin. It is primarily required by analytical laboratories, quality control units, and regulatory affairs departments within the pharmaceutical and fine chemical industries. The use of this well-characterized impurity standard is fundamental for ensuring drug safety, efficacy, and compliance with stringent global regulatory guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for method development, validation, and routine quality control testing of Nadifloxacin API and finished drug products.
• Impurity Profiling & Characterization: Used in analytical studies to identify, monitor, and quantify this specific stereoisomeric impurity to ensure it remains within acceptable limits as per ICH guidelines.
• Regulatory Compliance & Submission: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control and adherence to ICH Q3A(R2) and Q3B(R2).
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to track impurity formation over time and under various stress conditions.
• Process Chemistry R&D: Aids chemists in optimizing synthesis and purification processes to minimize the formation of this impurity, thereby improving yield and purity of the final Active Pharmaceutical Ingredient (API).
• Calibration & System Suitability: Used to calibrate analytical instruments like HPLC and UPLC, ensuring the accuracy and precision of impurity detection methods.

Basic Information

Item	Details
Product Name	Nadifloxacin Impurity 6 (S-Nadifloxacin Sulfate Sodium Salt)
CAS No.	1544562-94-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	S-Nadifloxacin Sulfate Sodium Salt; Nadifloxacin Sulfate Sodium Salt Impurity; Nadifloxacin Related Compound 6; (S)-9-Fluoro-6,7-dihydro-8-(4-hydroxypiperidin-1-yl)-5-methyl-1-oxo-1H,5H-benzo[i,j]quinolizine-2-carboxylic acid sulfate sodium salt; Nadifloxacin EP Impurity F; Nadifloxacin Sulfate Sodium; Nadifloxacin Stereoisomer Impurity
EINECS	Contact for details

Quality Control

Our Nadifloxacin Impurity 6 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and conformity to the highest standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for assay, related substances, and other critical parameters. Our quality commitment supports compliance with ICH, USP, and EP guidelines for pharmaceutical impurities.

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. Handle the container with care to prevent static discharge and physical damage.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 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.