Description

Pazufloxacin Impurity 14 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 antibiotic Pazufloxacin mesilate. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) departments, and contract research organizations (CROs) for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Pazufloxacin mesilate active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods in compliance with ICH Q2(R1) and Q3B(R2) guidelines.
• Quality Control & Batch Release Testing: Essential for routine QC testing to monitor impurity levels and ensure drug substance and product specifications are met for every production batch.
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing characterized impurity data for drug approval processes.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation and behavior of this specific impurity over time and under various stress conditions.
• Academic & Contract Research: Used in university and CRO settings for pharmacological research, metabolic studies, and forensic analysis related to fluoroquinolone antibiotics.

Basic Information

Product Name	Pazufloxacin Impurity 14
CAS No.	165071-09-0
Molecular Formula	C16H15FN2O4
Molecular Weight	318.30 g/mol
Synonyms	Pazufloxacin Related Compound 14; 7-[(3S)-3-Amino-1-pyrrolidinyl]-8-chloro-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic Acid; 8-Chloro Pazufloxacin; Pazufloxacin 8-Chloro Impurity; Pazufloxacin Chloro Impurity; (3S)-7-(3-Aminopyrrolidin-1-yl)-8-chloro-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid
EINECS	Contact for details

Quality Control

Our Pazufloxacin Impurity 14 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. Certificates of Analysis (COA) are provided, detailing comprehensive test results and confirming compliance with in-house specifications aligned with ICH guidelines. We support GMP-grade production for regulatory applications upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a desiccated environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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