Description

Posaconazole-D5 is a deuterated analog of the potent triazole antifungal agent, Posaconazole, specifically labeled with five deuterium atoms. This stable isotope-labeled compound is an essential reference standard and internal standard for the precise quantification and pharmacokinetic studies of Posaconazole in complex biological matrices using advanced analytical techniques like LC-MS/MS. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in drug development, bioequivalence studies, and clinical research to ensure accurate and reliable data.

Application

• Internal Standard for Bioanalysis: Serves as a critical internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) methods for the accurate quantification of Posaconazole in plasma, serum, and other biological samples.
• Metabolism and Pharmacokinetic (PK) Studies: Used as a tracer to investigate the absorption, distribution, metabolism, and excretion (ADME) profile of Posaconazole in preclinical and clinical research.
• Drug Impurity Profiling and Characterization: Aids in the identification and characterization of potential deuterated metabolites or process-related impurities during drug development.
• Reference Material for Method Development: Essential for developing, validating, and transferring robust analytical methods in compliance with GLP and GMP guidelines.
• Clinical Research and Therapeutic Drug Monitoring (TDM): Supports studies aimed at optimizing dosing regimens and monitoring drug levels in patients for improved therapeutic outcomes.

Basic Information

Product Name	Posaconazole-D5
CAS No.	1217785-83-5
Molecular Formula	C37H37D5F2N8O4
Molecular Weight	707.80 g/mol (deuterated form)
Synonyms	Posaconazole-d5; Deuterated Posaconazole; 4-[4-[4-[4-[[(3R,5R)-5-(2,4-Difluorophenyl)tetrahydro-5-(1H-1,2,4-triazol-1-ylmethyl)-3-furanyl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-[(2S,3S)-2-hydroxypentyl-3,3,4,4,4-d5]-3-triazol-2-one; (2S,3S)-2-Hydroxy-3-[4-[4-[4-[4-[[(3R,5R)-5-(2,4-difluorophenyl)-5-(1,2,4-triazol-1-ylmethyl)oxolan-3-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2,5-dihydro-1,2,4-triazol-1-yl]pentyl-3,3,4,4,4-d5 1,2,4-Triazol-1-one; SCH 56592-d5; Noxafil-d5
EINECS	Contact for details

Quality Control

Our Posaconazole-D5 is manufactured under strict quality-controlled conditions to ensure the highest standards of isotopic purity and chemical integrity, suitable for sensitive analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing critical parameters such as isotopic enrichment (D-content), chemical purity (by HPLC), and identity confirmation (by NMR and MS). We adhere to relevant industry guidelines to support your regulatory submissions.

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 should be handled in a dry environment to maintain stability. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-content)	≥ 98 atom % D
Chemical Purity (by NMR)	Conforms
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 1.0%

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