Description

(±)-Ketoconazole-D4 (Piperazine-3,3,5,5-D4) (cis-Isomers) is a deuterium-labeled analog of the broad-spectrum antifungal agent ketoconazole, specifically labeled on the piperazine ring. This compound is a critical internal standard and reference material for quantitative bioanalytical methods, ensuring accurate and reliable measurement of ketoconazole and its metabolites in complex biological matrices. It is essential for researchers and quality control laboratories in the pharmaceutical, biotechnology, and contract research organization (CRO) sectors who require high-purity, well-characterized standards for method development, validation, and regulatory compliance.

Application

• Bioanalytical Method Development & Validation: Serves as a stable isotope-labeled internal standard (SIL-IS) for Liquid Chromatography-Mass Spectrometry (LC-MS/MS) analysis of ketoconazole in pharmacokinetic and toxicokinetic studies.
• Drug Metabolism and Pharmacokinetics (DMPK): Enables precise quantification of parent drug and metabolite concentrations in plasma, serum, and tissue samples, improving data accuracy.
• Clinical Research & Therapeutic Drug Monitoring (TDM): Used in assays to monitor ketoconazole levels in patients, aiding in dose optimization and safety profiling.
• Pharmaceutical Quality Control: Acts as a reference standard for impurity profiling and assay determination of ketoconazole in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Forensic & Anti-Doping Analysis: Supports the detection and confirmation of ketoconazole in forensic toxicology and sports doping control samples.
• Metabolite Identification Studies: Assists in the structural elucidation of ketoconazole metabolites by providing a mass spectrometric reference point.

Basic Information

Product Name	(±)-Ketoconazole-D4 (Piperazine-3,3,5,5-D4) (cis-Isomers)
CAS No.	1398065-75-2
Molecular Formula	C26H24D4Cl2N4O4
Molecular Weight	531.44 g/mol (for D4 labeled form)
Synonyms	Ketoconazole-d4; 1-Acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine-3,3,5,5-d4; cis-Ketoconazole-d4; Deuterated Ketoconazole (piperazine-d4); Ketoconazole (piperazine-3,3,5,5-d4); Ketoconazole Internal Standard; Ketoconazole-d4 (cis-isomers); 1H-Imidazole, 1-[4-[[4-[(2,4-dichlorophenyl)methoxy]phenyl](1,3-dioxolan-2-yl)methyl]-, labeled with deuterium
EINECS	Contact for details

Quality Control

Our deuterated standards are manufactured under strict quality control protocols to ensure the highest isotopic purity and chemical integrity. Each batch is characterized using advanced analytical techniques including NMR, HPLC, and High-Resolution Mass Spectrometry (HRMS). A comprehensive Certificate of Analysis (COA) is provided, detailing isotopic enrichment (typically >98% D), chemical purity, and chromatographic data, supporting compliance with GLP/GMP guidelines for research and regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container sealed in a dry and well-ventilated place. For long-term storage, consider storing desiccated at -20°C.

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 (D4)	≥98 atom % D
Water Content (KF)	≤0.5%
Residue on Ignition	≤0.1%

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