Description

Enoxacin-(Piperazinyl-D8) Hydrate is a deuterated analog of the fluoroquinolone antibiotic enoxacin, specifically labeled on the piperazinyl moiety. This stable isotope-labeled compound is a critical reference standard and internal standard for quantitative bioanalytical methods, ensuring accuracy and reliability in pharmacokinetic and metabolic studies. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in drug development, metabolism research, and regulatory compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified primary standard for the identification and quantification of enoxacin and its metabolites in complex matrices.
• Mass Spectrometry Internal Standard: Used in LC-MS/MS and GC-MS assays to correct for variability in sample preparation and instrument analysis, improving data precision.
• Drug Metabolism and Pharmacokinetics (DMPK): Essential for conducting absorption, distribution, metabolism, and excretion (ADME) studies in preclinical and clinical research.
• Bioanalytical Method Development & Validation: A key component in developing and validating robust analytical methods for regulatory submissions to agencies like the FDA and EMA.
• Clinical Research: Enables accurate therapeutic drug monitoring (TDM) and bioavailability/bioequivalence studies for enoxacin formulations.
• Isotope Dilution Analysis: Employed in high-precision quantitative analysis to determine the concentration of unlabeled enoxacin in biological and environmental samples.

Basic Information

Item	Detail
Product Name	Enoxacin-(Piperazinyl-D8) Hydrate
CAS No.	1329642-60-5
Molecular Formula	C15H9D8FN4O3 · xH2O
Molecular Weight	Contact for details
Synonyms	1-Ethyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl-D8)-1,8-naphthyridine-3-carboxylic Acid Hydrate; Enoxacin D8 (Piperazinyl); Enoxacin-d8; Enoxacin (Piperazine-d8); Deuterated Enoxacin; Enoxacin Internal Standard; Enoxacin Stable Isotope; 1,8-Naphthyridine-3-carboxylic acid, 1-ethyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl-2,2,3,3,5,5,6,6-d8)-, hydrate
EINECS	Contact for details

Quality Control

Every batch of Enoxacin-(Piperazinyl-D8) Hydrate is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data to confirm identity, chemical purity, isotopic purity (enrichment), and exact water content. A detailed Certificate of Analysis (COA) is supplied with each shipment, reporting results from NMR, HPLC, LC-MS, and Karl Fischer titration. Our quality commitment ensures the material meets the stringent requirements for use in regulated bioanalysis and as a certified reference material.

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 compound is hygroscopic (moisture-sensitive); the original container should be kept sealed in a desiccated environment to maintain stability and purity. For long-term storage, consider conditions under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (NMR)	Conforms to structure
Identification (HPLC)	Conforms to reference
Purity (HPLC)	≥ 98.0%
Isotopic Purity (Enrichment)	≥ 98 atom % D
Water Content (KF)	Contact for details
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.