Description

Prulifloxacin Impurity CAS NO 156834-57-0 is a high-purity chemical reference standard used in the pharmaceutical development and manufacturing process. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Prulifloxacin. It is primarily required by analytical laboratories and pharmaceutical companies for method development, validation, and routine quality control testing. The availability of well-characterized impurities is essential for meeting stringent pharmacopeial standards and regulatory filings.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Prulifloxacin API and finished drug products.
• Analytical Method Development: Used in research and quality control (QC) laboratories to develop and validate HPLC, UPLC, or LC-MS methods for impurity profiling.
• Regulatory Compliance & Filings: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Stability Studies: Employed as a marker to monitor the formation of degradation products in Prulifloxacin formulations under various stress conditions.
• Quality Assurance/Control (QA/QC): Used for routine batch release testing to ensure Prulifloxacin API meets specified purity limits as per ICH Q3A/B guidelines.
• Process Chemistry Research: Aids chemists in understanding and optimizing the synthesis pathway of Prulifloxacin to minimize the formation of this specific impurity.

Basic Information

Product Name	Prulifloxacin Impurity
CAS No.	156834-57-0
Molecular Formula	C21H20FN3O3S
Molecular Weight	413.46 g/mol
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; Ulifloxacin Impurity; NM441 Impurity; (RS)-6-Fluoro-1-methyl-7-(4-(5-methyl-2-oxo-1,3-dioxol-4-yl)methylpiperazin-1-yl)-4-oxo-4H-thiazeto[3,2-a]quinoline-3-carboxylic acid; Prulifloxacin Related Compound; Prulifloxacin EP Impurity; Prulifloxacin USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Prulifloxacin Impurity (CAS 156834-57-0) is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure high purity and consistent quality. Our quality system is designed to meet the exacting standards of pharmaceutical reference material users. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for identity, purity, and impurity content as determined by advanced chromatographic techniques. We support compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere at -20°C to ensure maximum stability.

Specification

Item	Specification
Appearance	White to Off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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