Description

Delafloxacin Impurity 1 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 Delafloxacin. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard for the identification and quantification of impurities in Delafloxacin API and finished drug products.
• Analytical Method Development and Validation (HPLC, LC-MS) in quality control laboratories.
• Stability Studies and forced degradation studies to monitor impurity formation.
• Regulatory Compliance and Documentation for drug master files (DMF) and regulatory submissions (e.g., FDA, EMA).
• Research and Development of Delafloxacin synthesis pathways and impurity isolation.
• Calibration of analytical instruments for precise impurity measurement.

Basic Information

Product Name	Delafloxacin Impurity 1
CAS No.	2097714-10-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1-Deoxy-1-(methylamino)-D-glucitol Impurity of Delafloxacin; Delafloxacin Related Compound 1; Delafloxacin Process Impurity; (1S,2S,3R,4R,5S)-4-Fluoro-2,3,4,5-tetrahydro-1-(1-methyl-1H-1,2,3-triazol-4-yl)-1H-1-benzazepin-8-ol Impurity; ABT-492 Impurity 1; RX-3341 Impurity; WCK 771 Impurity 1
EINECS	Contact for details

Quality Control

Our Delafloxacin Impurity 1 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification by spectroscopic methods (IR, MS, NMR). We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, ensuring traceability and compliance with ICH guidelines for impurities in new drug substances (Q3A(R2)).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the product label or COA. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C

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