Description

Pazufloxacin Impurity 16 is a designated impurity standard used in the analytical profiling and quality control of the fluoroquinolone antibiotic, Pazufloxacin. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product. It serves as a key reference material for method development, validation, and regulatory compliance in the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Pazufloxacin Impurity 16 in active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurities during stability studies.
• Quality Control & Batch Release: Used in routine QC testing to confirm that Pazufloxacin API and formulations meet stringent pharmacopeial (e.g., USP, EP, JP) or internal specification limits for related substances.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., ANDA, NDA, CTA) by providing characterized impurity data required by agencies like the FDA, EMA, and PMDA.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (light, heat, humidity) as per ICH guidelines.
• Research & Development: Facilitates process chemistry research to understand and minimize the formation of this impurity during the synthesis of Pazufloxacin.

Basic Information

Product Name	Pazufloxacin Impurity 16
CAS No.	165071-10-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pazufloxacin Related Compound 16; Pazufloxacin EP Impurity 16; Pazufloxacin USP Impurity 16; (-)-9-Fluoro-6,7-dihydro-8-(4-hydroxypiperidin-1-yl)-5-methyl-1-oxo-1H,5H-benzo[i,j]quinolizine-2-carboxylic acid; 1-Cyclopropyl-6-fluoro-8-methoxy-7-[(3aS,7aS)-octahydro-1H-pyrrolo[3,4-b]pyridin-6(2H)-yl]-4-oxo-1,4-dihydroquinoline-3-carboxylic acid impurity; Pazufloxacin Degradant 16
EINECS	Contact for details

Quality Control

Our Pazufloxacin Impurity 16 is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, LC-MS, NMR, and IR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with cGMP, ICH Q3A/B, and relevant pharmacopeial guidelines (USP, EP).

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. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to ensure stability.

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)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
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.