Description

Levofloxacin-D8 is a deuterium-labeled analog of the broad-spectrum fluoroquinolone antibiotic Levofloxacin, serving as a critical internal standard for precise analytical quantification. This high-purity stable isotope-labeled compound is essential for ensuring accuracy and reliability in pharmacokinetic, metabolic, and bioanalytical studies. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in drug development and quality control.

Application

• Internal Standard for LC-MS/MS: Used as a quantitative reference in liquid chromatography-tandem mass spectrometry (LC-MS/MS) for the analysis of Levofloxacin in biological matrices (plasma, serum, urine).
• Drug Metabolism and Pharmacokinetics (DMPK): Facilitates accurate tracking of the parent drug's absorption, distribution, metabolism, and excretion (ADME) profiles in preclinical and clinical studies.
• Bioanalytical Method Development and Validation: Critical for developing, validating, and ensuring the reproducibility of analytical methods in compliance with FDA, EMA, and ICH guidelines.
• Pharmaceutical Quality Control: Supports impurity profiling, assay development, and stability testing of Levofloxacin drug substances and products.
• Isotope Dilution Mass Spectrometry (IDMS): Enables highly accurate and precise quantification, minimizing matrix effects and instrument variability.
• Clinical Research: Assists in therapeutic drug monitoring (TDM) and bioavailability/bioequivalence studies for generic drug development.

Basic Information

Product Name	Levofloxacin-D8
CAS No.	1217716-71-6
Molecular Formula	C18H12D8FN3O4
Molecular Weight	369.39 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-d8; (S)-(-)-Ofloxacin-d8; Levofloxacin (D8); Levofloxacin-d8 Isotope; Levofloxacin Deuterated Standard; Tavanic-d8; Cravit-d8
EINECS	Contact for details

Quality Control

Our Levofloxacin-D8 is manufactured under strict quality systems to ensure the high chemical and isotopic purity required for sensitive analytical applications. Each batch is characterized by advanced spectroscopic and chromatographic techniques, including NMR, HPLC, and MS, to confirm identity, purity, and deuterium incorporation. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C in a dry, cool place. The product is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to minimize exposure to atmospheric humidity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-content)	≥ 98.0 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.