Description

Ofloxacin Ep Impurity D Ethyl Ester is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity in the quality control and regulatory compliance of the active pharmaceutical ingredient (API) Ofloxacin. It is essential for analytical laboratories and manufacturers engaged in method development, validation, and ensuring batch-to-batch consistency. This material is vital for meeting stringent pharmacopoeial standards, including the European Pharmacopoeia (EP).

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the analysis of Ofloxacin API.
• Analytical Method Development: Crucial for developing and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in-house by API manufacturers to monitor and control impurity levels during production.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing necessary impurity identification and quantification data.
• Stability Studies: Employed to identify and track degradation products in Ofloxacin formulations under various stress conditions.
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of fluoroquinolone antibiotics.

Basic Information

Product Name	Ofloxacin Ep Impurity D Ethyl Ester
CAS No.	2172959-66-7
Molecular Formula	C19H20FN3O4
Molecular Weight	373.38 g/mol
Synonyms	Ethyl 9-fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylate; Ofloxacin Ethyl Ester Impurity; Ofloxacin Impurity D (Ethyl Ester); Ofloxacin Related Compound D; 7H-[1,4]Oxazino[2,3,4-ij]quinoline-6-carboxylic acid, 9-fluoro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-, ethyl ester; OFX Impurity D Ethyl Ester
EINECS	Contact for details

Quality Control

Every batch of Ofloxacin Ep Impurity D Ethyl Ester is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to meet the exacting requirements of pharmaceutical impurity standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced chromatographic and spectroscopic methods. We support compliance with EP, USP, and ICH guidelines.

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); the container must be kept tightly sealed 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.