Description

Prulifloxacin Impurity CAS NO 173599-92-3 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) Prulifloxacin. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, stability studies, and impurity profiling. The availability of a well-characterized impurity standard is essential for maintaining stringent quality control in pharmaceutical production.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of specific impurities in Prulifloxacin API and finished drug products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity detection.
• Quality Control and Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., ICH Q3A/B guidelines).
• Stability Studies: Acts as a marker in forced degradation and long-term stability studies to track impurity formation over time and under various stress conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough understanding and control of the drug substance's impurity profile.
• Research and Development: Utilized in synthetic chemistry research to study degradation pathways and to synthesize and characterize related substances.

Basic Information

Product Name	Prulifloxacin Impurity
CAS No.	173599-92-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	6-Fluoro-1-methyl-7-[4-(5-methyl-2-oxo-1,3-dioxolen-4-yl)methyl-1-piperazinyl]-4-oxo-4H-[1,3]thiazeto[3,2-a]quinoline-3-carboxylic Acid (Related Compound); Prulifloxacin Related Compound; Prulifloxacin Process Impurity; Prulifloxacin Degradant; NM441 Impurity; UNII-9FZ6Y9W0QH; AF 3013 Impurity
EINECS	Contact for details

Quality Control

Every batch of Prulifloxacin Impurity (CAS 173599-92-3) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure compliance with industry and research standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH guidelines and can supply materials suitable for regulatory submission purposes.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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