Description

Ofloxacin Ep Impurity C is a high-purity chemical reference standard, specifically identified as a process-related impurity of the fluoroquinolone antibiotic Ofloxacin. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products. It is primarily required by analytical laboratories and pharmaceutical manufacturers for use in method development, validation, and quality control testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Ofloxacin Ep Impurity C in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, to separate and analyze impurities in Ofloxacin.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity profiles and ensure drug substance purity meets pharmacopeial specifications (e.g., EP, USP).
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Used as a marker to track the formation of degradation products in Ofloxacin formulations under various stress conditions.
• Research & Development (R&D): Facilitates research into the synthesis pathways, degradation mechanisms, and toxicological profiles of Ofloxacin-related compounds.

Basic Information

Product Name	Ofloxacin Ep Impurity C
CAS No.	95848-94-5
Molecular Formula	C18H20FN3O4
Molecular Weight	361.37 g/mol
Synonyms	9-Fluoro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic Acid; Ofloxacin Impurity C; Ofloxacin Related Compound C; (RS)-9-Fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic Acid; OFX Imp C
EINECS	Contact for details

Quality Control

Every batch of Ofloxacin Ep Impurity C is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including HPLC for purity and identity confirmation, to ensure it meets the high standards required for pharmaceutical impurity analysis. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with the requirements for chemical reference materials used in GMP environments.

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 product is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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