Description

Pazufloxacin Impurity 7 is a specified impurity and degradation product of the fluoroquinolone antibiotic, Pazufloxacin. This compound is critical for analytical research and quality control processes in pharmaceutical development and manufacturing. It is primarily used by researchers and quality assurance professionals in the pharmaceutical industry for method validation, stability studies, and ensuring the purity and safety of the active pharmaceutical ingredient (API).

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Pazufloxacin API and finished drug products.
• Analytical Method Development and Validation (HPLC/LC-MS): Used as a critical component for developing, optimizing, and validating chromatographic methods to monitor impurity profiles.
• Stability Studies and Forced Degradation Testing: Employed to understand the degradation pathways of Pazufloxacin and to establish stability-indicating methods.
• Quality Control and Batch Release Testing: Essential for setting impurity specifications and ensuring batch-to-batch consistency and compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides necessary data on impurity characterization for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Research and Development: Used in synthetic chemistry and pharmacology research to study the structure-activity relationship and metabolism of fluoroquinolones.

Basic Information

Product Name	Pazufloxacin Impurity 7
CAS No.	171567-48-9
Molecular Formula	C16H15FN2O4
Molecular Weight	318.30 g/mol
Synonyms	Pazufloxacin Related Compound 7; 1-Cyclopropyl-6-fluoro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid Impurity; (-)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic Acid Impurity 7; Pazufloxacin EP Impurity C; Pazufloxacin USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Pazufloxacin Impurity 7 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, LC-MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant pharmacopeial 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 desiccated at 2-8°C.

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)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% 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.