Description

Pazufloxacin Impurity 5 is a designated impurity standard used in the analytical profiling and quality control of the fluoroquinolone antibiotic, Pazufloxacin. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Pazufloxacin Impurity 5 in Pazufloxacin API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing and validating stability-indicating chromatographic methods to monitor impurity profiles.
• Quality Control & Batch Release Testing: A critical component in the QC testing suite to ensure API batches meet pharmacopeial (e.g., USP, EP, JP) or internal specification limits for related substances.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Used in R&D to understand the degradation pathways and synthesis by-products of Pazufloxacin.

Basic Information

Product Name	Pazufloxacin Impurity 5
CAS No.	165071-05-6
Molecular Formula	C16H15FN2O4
Molecular Weight	318.30 g/mol
Synonyms	(-)-9-Fluoro-6,7-dihydro-8-(4-hydroxy-1-piperazinyl)-5-methyl-1-oxo-1H,5H-benzo[i,j]quinolizine-2-carboxylic acid; 9-Fluoro-8-(4-hydroxy-1-piperazinyl)-5-methyl-6,7-dihydro-1-oxo-1H,5H-benzo[i,j]quinolizine-2-carboxylic acid; Pazufloxacin Related Compound B; Pazufloxacin EP Impurity B; Pazufloxacin USP Impurity; Pazufloxacin Degradant
EINECS	Contact for details

Quality Control

Every batch of Pazufloxacin Impurity 5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.2%

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