Description

Pazufloxacin Impurity 5 is a designated impurity standard of the fluoroquinolone antibiotic, Pazufloxacin. This high-purity reference material is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is essential for researchers and quality assurance professionals in the pharmaceutical and fine chemical industries who require reliable standards to ensure drug purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Pazufloxacin Impurity 5 in active pharmaceutical ingredient (API) and finished drug product analysis.
• Analytical Method Development & Validation (HPLC/LC-MS): Serves as a critical component in developing and validating stability-indicating chromatographic methods for Pazufloxacin.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity profiles, ensuring compliance with ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Facilitates research into the degradation pathways, pharmacokinetics, and metabolic profile of Pazufloxacin.

Basic Information

Product Name	Pazufloxacin Impurity 5
CAS No.	777824-29-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pazufloxacin Related Compound 5; Pazufloxacin EP Impurity 5; Pazufloxacin USP Impurity 5; (-)-9-Fluoro-6,7-dihydro-8-(4-hydroxypiperidin-1-yl)-5-methyl-1-oxo-1H,5H-benzo[i,j]quinolizine-2-carboxylic acid (Potential IUPAC); Pazufloxacin Degradation Product; Pazufloxacin Process Impurity
EINECS	Contact for details

Quality Control

Our Pazufloxacin Impurity 5 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification by spectroscopic methods (IR, MS, NMR), to ensure it meets the high standards required for pharmaceutical impurity analysis. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The product is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single impurity ≤ 1.0%; Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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