Description

Everolimus-D4 is a deuterated analog of the potent mTOR inhibitor Everolimus, specifically designed for use as an internal standard in quantitative bioanalytical studies. This high-purity stable isotope-labeled compound is essential for ensuring the accuracy and reliability of mass spectrometry-based assays, particularly in pharmacokinetic and metabolic research. It is a critical tool for pharmaceutical R&D and clinical laboratories engaged in the development and therapeutic monitoring of immunosuppressant and oncology drugs.

Application

• Bioanalytical Internal Standard: Primary use as a deuterated internal standard for the precise quantification of Everolimus in biological matrices (e.g., plasma, serum) via LC-MS/MS.
• Pharmacokinetic (PK) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical trials.
• Metabolite Identification: Aids in distinguishing drug-derived metabolites from endogenous compounds in complex biological samples.
• Method Development & Validation: Critical for developing, optimizing, and validating robust analytical methods in compliance with GLP and FDA/EMA guidelines.
• Therapeutic Drug Monitoring (TDM): Supports accurate assay calibration for monitoring Everolimus blood levels in transplant and cancer patients.
• Drug-Drug Interaction Studies: Used in research investigating the impact of co-administered drugs on Everolimus metabolism.

Basic Information

Item	Detail
Product Name	Everolimus-D4
CAS No.	1338452-54-2
Molecular Formula	C53H79D4NO14
Molecular Weight	974.27 g/mol (approx.)
Synonyms	42-O-(2-Hydroxyethyl)rapamycin-d4; RAD001-d4; Afinitor-d4; Certican-d4; Deuterated Everolimus; Everolimus (tetradeuterated); (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-Dihydroxy-12-[(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl]-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentone-d4
EINECS	Contact for details

Quality Control

Our Everolimus-D4 is manufactured under strict quality control protocols to ensure the highest isotopic and chemical purity required for sensitive analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results for assay, isotopic enrichment, and impurity profiles. We adhere to standards relevant for high-purity reference materials used in regulated bioanalysis.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below. This product is hygroscopic (moisture-sensitive). Allow the vial to equilibrate to room temperature in a desiccator before opening to prevent moisture condensation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC-MS)	Conforms
Assay (HPLC)	≥ 98.0%
Isotopic Purity (Deuterium Enrichment)	≥ 98 atom % D
Chemical Purity (HPLC)	≥ 98.0%
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.