Description

Pazufloxacin Impurity 6 is a specified impurity and degradation product of the fluoroquinolone antibiotic, Pazufloxacin. This high-purity reference standard 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 industry who require reliable standards for impurity profiling and regulatory compliance.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Pazufloxacin Mesylate active pharmaceutical ingredient (API) and finished drug products.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) to ensure specificity and accuracy.
• Essential for pharmaceutical quality control (QC) and stability studies to monitor degradation pathways.
• Used in regulatory compliance and submission packages (e.g., for FDA, EMA) to establish impurity thresholds (ICH guidelines Q3A/B).
• Supports research and development of Pazufloxacin generics and related fluoroquinolone compounds.
• Valuable for pharmacopoeial testing and establishing monograph specifications.

Basic Information

Product Name	Pazufloxacin Impurity 6
CAS No.	164851-44-9
Molecular Formula	C16H15FN2O4
Molecular Weight	318.30 g/mol
Synonyms	Pazufloxacin Related Compound 6; (-)-10-(1-Aminocyclopropyl)-9-fluoro-2,3-dihydro-3-methyl-7-oxo-7H-pyrido[1,2,3-de][1,4]benzoxazine-6-carboxylic Acid; (3S)-10-(1-Aminocyclopropyl)-9-fluoro-3-methyl-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic Acid; Pazufloxacin Impurity B; Pazufloxacin EP Impurity B; Pazufloxacin Mesylate Impurity 6
EINECS	Contact for details

Quality Control

Every batch of Pazufloxacin Impurity 6 is manufactured and handled under strict quality management systems. The product undergoes comprehensive analytical testing, including HPLC for purity confirmation and structural elucidation via spectroscopic methods (NMR, MS). A detailed Certificate of Analysis (COA) is provided with each shipment, confirming identity, purity, and chromatographic profile. Our quality standards are designed to meet the rigorous demands of pharmaceutical reference material applications.

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 nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider desiccants or 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%
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.