Description

Isavuconazole-D4 is a deuterium-labeled analog of the potent antifungal agent isavuconazole, specifically designed for use as an internal standard in quantitative analytical methods. This high-purity reference material is critical for ensuring accuracy and reliability in pharmacokinetic, metabolic, and bioanalytical studies. It is an essential tool for pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory agencies involved in the development and quality control of antifungal therapeutics.

Application

• Internal Standard for LC-MS/MS: Primary application as a stable, non-interfering internal standard for the precise quantification of isavuconazole in complex biological matrices (e.g., plasma, serum, tissue homogenates) using liquid chromatography-tandem mass spectrometry.
• Drug Metabolism and Pharmacokinetics (DMPK): Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles in preclinical and clinical studies.
• Bioanalytical Method Development and Validation: Serves as a critical component in developing, optimizing, and validating robust analytical methods compliant with FDA, EMA, and ICH guidelines.
• Clinical Trial Support: Used in therapeutic drug monitoring (TDM) and bioequivalence studies to ensure patient safety and efficacy data integrity.
• Pharmaceutical Impurity Profiling: Aids in the identification and quantification of potential deuterated impurities or related substances in active pharmaceutical ingredient (API) batches.
• Forensic and Toxicological Analysis: Supports accurate measurement of isavuconazole levels in forensic investigations or cases of suspected overdose.

Basic Information

Product Name	Isavuconazole-D4
CAS No.	1346598-58-0
Molecular Formula	C22H13D4F2N5O2
Molecular Weight	~ 437.43 g/mol
Synonyms	Isavuconazole-d4; (2R,3R)-3-(4-(4-Cyclopentylpiperazin-1-yl)phenyl)-2-(2,5-difluorophenyl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol-d4; BAL8557-d4; RO0094815-d4; Cresemba-d4 (labeled); [2H4]-Isavuconazole; Deuterated Isavuconazole
EINECS	Contact for details

Quality Control

Every batch of Isavuconazole-D4 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of chemical purity, isotopic enrichment, and structural identity. Our quality commitment includes comprehensive characterization by NMR, HPLC, and mass spectrometry. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific data for isotopic purity (D-enrichment), chemical purity, and other critical parameters to support your 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. This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98.0 atom % D
Chemical Purity (by HPLC)	≥ 95.0%
Water Content (KF)	≤ 1.0%
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.