Description

Difloxacin-D3 Hydrochloride Hydrate is a deuterium-labeled analog of the veterinary fluoroquinolone antibiotic difloxacin, used as a critical internal standard in quantitative bioanalytical methods. Its primary value lies in enabling precise and accurate measurement of the parent drug in complex biological matrices through mass spectrometry, ensuring reliable pharmacokinetic and residue depletion studies. This high-purity reference material is essential for research laboratories, contract research organizations (CROs), and regulatory bodies focused on veterinary drug development, food safety analysis, and metabolic research. The compound is supplied with a detailed data sheet to support method validation and regulatory submissions.

Application

• Internal Standard for LC-MS/MS: Serves as a stable isotope-labeled internal standard for the precise quantification of difloxacin in biological samples (e.g., plasma, tissue, milk) via liquid chromatography-tandem mass spectrometry.
• Veterinary Pharmacokinetics: Enables accurate determination of absorption, distribution, metabolism, and excretion (ADME) profiles of difloxacin in food-producing and companion animals.
• Residue Analysis & Food Safety: Critical for developing and validating analytical methods to monitor difloxacin residues in animal-derived food products to ensure compliance with maximum residue limits (MRLs).
• Metabolic Pathway Studies: Used in research to investigate and characterize the metabolic pathways and biotransformation products of difloxacin.
• Method Development & Validation: Supports the development, optimization, and validation of robust bioanalytical methods in compliance with guidelines like FDA 21 CFR Part 58 (GLP).
• Quality Control in Reference Material Production: Acts as a key calibrant or system suitability standard in the quality control of non-labeled difloxacin API or finished dosage forms.

Basic Information

Item	Details
Product Name	Difloxacin-D3 Hydrochloride Hydrate
CAS No.	1173021-89-0
Molecular Formula	C21H16D3F2N3O3 • HCl • xH2O
Molecular Weight	Contact for details
Synonyms	Difloxacin-d3 HCl Hydrate; 6-Fluoro-1,4-dihydro-1-(deuteriomethyl)-7-(4-ethyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid hydrochloride hydrate; 1-Cyclopropyl-6-fluoro-1,4-dihydro-7-(4-ethyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid-d3 hydrochloride hydrate; Deuterated Difloxacin Hydrochloride Hydrate; [2H3]-Difloxacin Hydrochloride Hydrate; Difloxacin (methyl-d3) Hydrochloride Hydrate; Internal Standard for Difloxacin Quantitation
EINECS	Contact for details

Quality Control

Our Difloxacin-D3 Hydrochloride Hydrate is manufactured under strict quality control protocols to ensure the high chemical purity and isotopic enrichment required for analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing parameters such as chemical purity (by HPLC), isotopic purity (by MS), water content (Karl Fischer), and residual solvents. We adhere to relevant industry standards for reference materials, and our quality system supports traceability and consistency for research and regulatory purposes.

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) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under 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	≥ 98.0 atom % D
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits

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