Description

Sparfloxacin Impurity CAS NO 1348790-48-6 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 fluoroquinolone antibiotic Sparfloxacin. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. Our product is supplied with comprehensive documentation to support your quality control and research needs.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Sparfloxacin Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating HPLC, UPLC, or LC-MS methods to ensure accurate impurity detection.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine quality control testing to monitor batch-to-batch consistency and purity of Sparfloxacin.
• Regulatory Compliance & Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing characterized impurity standards required for stability studies and specification setting.
• Research & Development (R&D): Utilized in pharmaceutical R&D to study degradation pathways, synthesis by-products, and the stability profile of Sparfloxacin.
• Pharmacopoeial Standards: Can be used as a working standard in conjunction with official pharmacopoeial monographs (e.g., USP, EP) for impurity testing.

Basic Information

Product Name	Sparfloxacin Impurity
CAS No.	1348790-48-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sparfloxacin Related Compound; Sparfloxacin Impurity Standard; Sparfloxacin Process Impurity; 5-Amino-1-cyclopropyl-7-[(3R,5S)-3,5-dimethylpiperazin-1-yl]-6,8-difluoro-4-oxoquinoline-3-carboxylic acid impurity; (1-Cyclopropyl-6,8-difluoro-1,4-dihydro-7-[(3R,5S)-3,5-dimethyl-1-piperazinyl]-4-oxo-3-quinolinecarboxylic acid) Impurity; Fluoroquinolone Impurity; Antibiotic Impurity Standard
EINECS	Contact for details

Quality Control

Our Sparfloxacin Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and impurities. We support compliance with ICH Q3A/B guidelines and other relevant regulatory frameworks.

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 place. For long-term storage, consider storing under inert atmosphere to prevent potential degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
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%

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