Description

Norfloxacin Ep Impurity G is a high-purity chemical reference standard, specifically identified as a process-related impurity of the fluoroquinolone antibiotic Norfloxacin. This compound is critical for pharmaceutical research and development, serving as a key marker for ensuring drug purity, safety, and regulatory compliance. It is primarily used by analytical laboratories, quality control units, and R&D departments within the global pharmaceutical and fine chemical industries for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Norfloxacin Ep Impurity G in active pharmaceutical ingredient (API) batches.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods for impurity profiling of Norfloxacin.
• Quality Control & Assurance: Employed in routine QC testing to monitor and control impurity levels, ensuring final drug products meet pharmacopeial specifications (e.g., EP, USP).
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs).
• Stability Studies: Used as an analytical standard to track the formation of this specific impurity during forced degradation and long-term stability testing of Norfloxacin.
• Research & Development: Aids in synthetic route optimization and process chemistry studies to understand and minimize the formation of this impurity.

Basic Information

Product Name	Norfloxacin Ep Impurity G
CAS No.	70459-04-0
Molecular Formula	C16H18FN3O3
Molecular Weight	319.33 g/mol
Synonyms	1-Ethyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic Acid Ethyl Ester; Norfloxacin Ethyl Ester; Norfloxacin Impurity G; Norfloxacin Related Compound G; 1-Ethyl-6-fluoro-7-(piperazin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid ethyl ester; Ethyl 1-ethyl-6-fluoro-4-oxo-7-(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylate
EINECS	Contact for details

Quality Control

Every batch of Norfloxacin Ep Impurity G is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC, NMR, and MS analyses.

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 should be handled in a dry environment to prevent degradation.

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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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