Description

Pazufloxacin Impurity 15 is a specified impurity and reference standard used in the analytical profiling of the fluoroquinolone antibiotic, Pazufloxacin. This compound is critical for pharmaceutical research and development, enabling the accurate identification, quantification, and control of related substances during drug manufacturing. It is primarily utilized by analytical chemists and quality control laboratories in the pharmaceutical industry to ensure product purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the qualitative and quantitative analysis of Pazufloxacin and its related substances.
• Method Development and Validation: Essential for developing and validating robust analytical methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor and control the levels of this specific impurity, ensuring the final drug product meets stringent pharmacopeial specifications (e.g., ICH Q3A/B).
• Stability Studies: Employed to identify and track the formation of degradation products in Pazufloxacin drug substance and product under various stress conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify the control strategy.
• Research and Development: Aids in synthetic route optimization and process chemistry by helping to understand and minimize impurity formation.

Basic Information

Product Name	Pazufloxacin Impurity 15
CAS No.	165071-03-4
Molecular Formula	C16H15FN2O4
Molecular Weight	318.30 g/mol
Synonyms	Pazufloxacin Related Compound 15; 1-Cyclopropyl-6-fluoro-8-methoxy-7-(3-methylpiperazin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid; (-)-Pazufloxacin Impurity 15; (3S)-10-Fluoro-2,3-dihydro-3-methyl-7-oxo-7H-pyrido[1,2,3-de][1,4]benzoxazine-6-carboxylic acid impurity; Pazufloxacin EP Impurity C; Pazufloxacin USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Pazufloxacin Impurity 15 is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided with each shipment to support your quality and regulatory requirements.

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 material is hygroscopic (moisture-sensitive) and must be kept under dry conditions to prevent degradation. For long-term storage, consider desiccated conditions.

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 individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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