Description

Levofloxacin Related Compound C (25 mg) ((S)-ethyl 9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylate) is a high-purity reference standard and impurity used in the analytical profiling of the fluoroquinolone antibiotic, Levofloxacin. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical products by enabling precise identification and quantification of related substances. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments focused on method development, validation, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Levofloxacin-related impurities in active pharmaceutical ingredient (API) and finished drug product analysis.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release Testing: Essential for routine QC testing to monitor impurity levels and ensure batch-to-batch consistency of Levofloxacin API and formulations.
• Stability Studies: Employed as a marker to track the formation of degradation products during forced degradation and long-term stability studies of Levofloxacin products.
• Regulatory Submissions: Provides critical data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate thorough impurity characterization and control strategies to agencies like the FDA and EMA.
• Pharmacopeial Testing: Used for testing against monographs in the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and other international pharmacopeias.

Basic Information

Product Name	Levofloxacin Related Compound C (25 mg)
CAS No.	177472-30-9
Molecular Formula	C21H26FN3O5
Molecular Weight	419.45 g/mol
Synonyms	(S)-Ethyl 9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylate; Levofloxacin Impurity C; Levofloxacin Related Substance C; (S)-(-)-Ofloxacin Related Compound C; (3S)-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 ethyl ester; Ethyl (S)-9-fluoro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzoxazine-6-carboxylate
EINECS	Contact for details

Quality Control

Our Levofloxacin Related Compound C is manufactured and tested under strict quality management systems. Each batch undergoes comprehensive analytical characterization using advanced techniques including HPLC, GC, MS, and NMR to confirm identity, purity, and strength. We provide a detailed Certificate of Analysis (COA) with each unit, which includes batch-specific data and is traceable to primary reference standards. Our quality commitment aligns with the requirements for pharmaceutical impurity standards, supporting compliance with ICH, USP, and Ph. Eur. guidelines.

Storage

Preserve in the original, 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) and should be handled in a low-humidity environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.