Description

Levofloxacin (R)-Ofloxacin-D3 is a deuterium-labeled isotopologue of the active pharmaceutical ingredient Levofloxacin, a third-generation fluoroquinolone antibiotic. This high-purity reference standard is critical for ensuring analytical accuracy and regulatory compliance in pharmaceutical research and development. It is primarily utilized by analytical chemists and quality control laboratories in the pharmaceutical and contract research organization (CRO) sectors for method development, validation, and quantitative analysis.

Application

• Pharmaceutical Reference Standard: Serves as an internal standard or calibrant in quantitative bioanalytical methods (LC-MS/MS, HPLC) for pharmacokinetic and bioequivalence studies.
• Metabolism and Pharmacokinetic Research: Used as a stable isotope-labeled tracer to investigate the absorption, distribution, metabolism, and excretion (ADME) profile of Levofloxacin.
• Drug Impurity Profiling: Aids in the identification and quantification of process-related impurities and degradants in active pharmaceutical ingredient (API) batches.
• Clinical Research Assays: Enables precise and accurate measurement of Levofloxacin concentrations in biological matrices (plasma, serum, urine) during clinical trials.
• Quality Control & Assurance: Essential for the validation of analytical methods to ensure the identity, potency, and purity of commercial Levofloxacin drug products in compliance with pharmacopeial standards (USP, EP).
• Forensic and Anti-Doping Analysis: Used as a certified reference material in confirmatory testing protocols.

Basic Information

Product Name	Levofloxacin (R)-Ofloxacin-D3
CAS No.	1346617-10-4
Molecular Formula	C18H17D3FN3O4
Molecular Weight	364.38 g/mol (approximate)
Synonyms	(-)-(S)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic Acid-d3; (S)-(-)-Ofloxacin-d3; Levofloxacin-d3; (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-2,3,4-d3 Acid; Levofloxacin Deuterated; Levofloxacin Internal Standard
EINECS	Contact for details

Quality Control

Every batch of Levofloxacin (R)-Ofloxacin-D3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assessment, and isotopic enrichment verification using advanced techniques including NMR, HPLC, and Mass Spectrometry. Certificates of Analysis (COA) are provided, detailing batch-specific results for purity, chemical and isotopic composition, and confirming compliance with in-house specifications tailored for analytical reference standard use.

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 must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storage under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (deuterium incorporation)	≥ 98 atom % D
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.