Description

Deacetyl Ketoconazole-D8 is a deuterated analog of a key ketoconazole metabolite, specifically designed for use as an internal standard in analytical chemistry. This high-purity compound is essential for ensuring the accuracy and reliability of quantitative analyses, particularly in complex biological matrices. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers engaged in drug metabolism and pharmacokinetics (DMPK) studies, bioanalytical method development, and clinical research.

Application

• Internal Standard for LC-MS/MS: Critical for the precise quantification of ketoconazole and its metabolites in bioanalytical assays, ensuring method validity and regulatory compliance.
• Drug Metabolism Studies (DMPK): Used in pharmacokinetic and ADME (Absorption, Distribution, Metabolism, Excretion) research to track and quantify drug-derived compounds.
• Clinical Research & Therapeutic Drug Monitoring (TDM): Supports the accurate measurement of drug concentrations in patient plasma or serum samples.
• Pharmaceutical Impurity Profiling: Aids in the identification and quantification of related substances and degradation products during drug development and quality control.
• Forensic & Toxicological Analysis: Employed in confirmatory testing for the presence of antifungal agents in forensic investigations.
• Stable Isotope Labeled Research: Serves as a tracer in mechanistic studies of metabolic pathways and enzymatic processes.

Basic Information

Item	Details
Product Name	Deacetyl Ketoconazole-D8
CAS No.	1346602-18-3
Molecular Formula	C24H18D8Cl2N4O3
Molecular Weight	Approx. 489.42 g/mol
Synonyms	Ketoconazole D8 Metabolite; 1-Deacetyl Ketoconazole-D8; 1-Acetyl-4-[4-[[(2R,4S)-2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine-D8; Deuterated Deacetyl Ketoconazole; N-Desacetyl Ketoconazole-D8; Ketoconazole Impurity D8 (Deacetyl); (2R,4S)-2-(2,4-Dichlorophenyl)-2-[(1H-1,2,4-triazol-1-yl)methyl]-1,3-dioxolan-4-yl]methyl 4-[4-(piperazin-1-yl)phenyl] ether-D8
EINECS	Contact for details

Quality Control

Our Deacetyl Ketoconazole-D8 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC, NMR, and MS, to ensure high chemical and isotopic purity suitable for sensitive analytical applications. A comprehensive Certificate of Analysis (COA) detailing purity, isotopic enrichment, and identification data is provided with every shipment to support your quality and regulatory documentation needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability. For long-term storage, consider desiccant use.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98 atom % D
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.