Description

Fluconazole-D4 is a deuterated analog of the widely used antifungal agent fluconazole, specifically labeled with four deuterium atoms. This stable isotope-labeled compound is an essential reference standard and internal standard for precise quantitative analysis in pharmaceutical research and development. It is primarily utilized by analytical laboratories, contract research organizations (CROs), and pharmaceutical companies engaged in bioanalytical method development, pharmacokinetic studies, and drug metabolism research to ensure accurate and reliable mass spectrometry results.

Application

• Primary use as an internal standard for the quantification of fluconazole in biological matrices (e.g., plasma, serum) using LC-MS/MS and GC-MS.
• Critical component in bioanalytical method development and validation for regulatory submissions to agencies like the FDA and EMA.
• Reference material for drug metabolism and pharmacokinetics (DMPK) studies to track the parent drug.
• Used in clinical research to monitor drug levels in patients for therapeutic drug monitoring (TDM).
• Essential for pharmaceutical quality control labs performing impurity profiling and stability testing.
• Research tool in isotope dilution mass spectrometry to achieve high-precision measurements.

Basic Information

Product Name	Fluconazole-D4
CAS No.	1124197-58-5
Molecular Formula	C13H8D4F2N6O
Molecular Weight	310.30 g/mol
Synonyms	2-(2,4-Difluorophenyl)-1,3-bis(1H-1,2,4-triazol-1-yl)-2-propanol-d4; Fluconazole (phenyl-D4); Fluconazole-d4 (phenyl-D4); α-(2,4-Difluorophenyl)-α-(1H-1,2,4-triazol-1-ylmethyl)-1H-1,2,4-triazole-1-ethanol-d4; Deuterated Fluconazole; Fluconazole Internal Standard; Diflucan-d4 (labeled analog)
EINECS	Contact for details

Quality Control

Our Fluconazole-D4 is manufactured under controlled conditions to ensure the highest isotopic and chemical purity, meeting the stringent requirements for analytical reference standards. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing results for isotopic purity (D-enrichment), chemical purity (by HPLC), and identification (by NMR and MS). We adhere to cGMP principles for pharmaceutical reference standards, ensuring traceability, stability, and reliability for critical research applications.

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); ensure the container is sealed tightly after each use to prevent degradation from atmospheric moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98.0 atom % D
Chemical Purity (by NMR)	≥ 95.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Meets ICH guidelines

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