Description

Levofloxacin-13C-D3/ Ofloxacin-13C-D3 is a high-purity, stable isotope-labeled analog of the broad-spectrum fluoroquinolone antibiotic. This compound is an essential internal standard for the precise quantification of levofloxacin and ofloxacin in complex biological matrices using advanced analytical techniques. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory testing facilities. The product ensures accurate and reliable results in pharmacokinetic studies, bioequivalence testing, and clinical research, supporting critical drug development and quality control processes.

Application

• Internal Standard for LC-MS/MS: Serves as a critical reference compound for the accurate quantification of levofloxacin and ofloxacin in bioanalytical methods using liquid chromatography-tandem mass spectrometry.
• Pharmacokinetic and Metabolism Studies: Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Therapeutic Drug Monitoring (TDM): Used in clinical laboratories to develop robust assays for monitoring drug concentrations in patient serum or plasma to optimize dosing regimens.
• Veterinary Drug Residue Analysis: Applied in food safety testing to detect and quantify antibiotic residues in animal-derived products for regulatory compliance.
• Environmental Fate Studies: Supports research into the environmental persistence and breakdown of fluoroquinolone antibiotics in water and soil systems.
• Pharmaceutical Impurity Profiling: Aids in the development and validation of methods to identify and quantify related substances in active pharmaceutical ingredient (API) batches.
• Forensic Toxicology: Employed as a reference material in forensic analyses to confirm the presence of specific antibiotics in casework samples.

Basic Information

Product Name	Levofloxacin-13C-D3/ Ofloxacin-13C-D3
CAS No.	1261398-33-7
Molecular Formula	C18H17D3FN3O4 (13C labeled)
Molecular Weight	Contact for details
Synonyms	Levofloxacin-(13C,D3); Ofloxacin-(13C,D3); (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-13C-D3; (-)-(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-13C-D3; Levofloxacin Isotopically Labeled Standard; Ofloxacin Isotopically Labeled Standard; Levofloxacin Internal Standard; Ofloxacin Internal Standard
EINECS	Contact for details

Quality Control

Every batch of Levofloxacin-13C-D3/ Ofloxacin-13C-D3 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure high chemical purity, isotopic enrichment, and chromatographic performance suitable for sensitive analytical applications. Comprehensive Certificates of Analysis (COA) are provided, detailing results from NMR, HPLC, and MS analyses to confirm identity, purity, and isotopic labeling. Our quality commitment aligns with the standards expected for reference materials and certified standards used in regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term stability, consider storage under inert atmosphere or in a desiccator.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (NMR)	Conforms to structure
Identification (HPLC)	Conforms to reference
Purity (HPLC)	≥98.0%
Isotopic Enrichment	≥99 atom % 13C; ≥98 atom % D
Chemical Purity	≥95.0%
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.