Description

n-Boc-n-Desethyl Sunitinib-D5 is a deuterated isotopologue of a key intermediate used in the synthesis and metabolic study of the multi-targeted receptor tyrosine kinase inhibitor, Sunitinib. This compound is specifically designed for use as an internal standard in quantitative bioanalytical methods, ensuring high accuracy and reliability in pharmacokinetic and metabolism research. It is an essential material for pharmaceutical R&D laboratories, contract research organizations (CROs), and academic institutions focused on oncology drug development and analytical method validation.

Application

• Internal Standard for LC-MS/MS: Primary application as a stable, isotopically labeled internal standard for the precise quantification of Sunitinib and its metabolites in biological matrices (plasma, serum, tissue).
• Drug Metabolism and Pharmacokinetics (DMPK): Critical for conducting mass spectrometry-based studies to understand the absorption, distribution, metabolism, and excretion (ADME) profile of Sunitinib.
• Analytical Method Development & Validation: Used to develop, optimize, and validate robust, sensitive, and specific bioanalytical assays in compliance with GLP and FDA/EMA guidelines.
• Pharmaceutical Impurity Profiling: Aids in the identification and characterization of process-related impurities and degradation products during drug substance manufacturing.
• Clinical Research: Supports therapeutic drug monitoring (TDM) and clinical trial sample analysis to correlate drug exposure with efficacy and safety outcomes.
• Isotope Dilution Mass Spectrometry (IDMS): Enables highly accurate absolute quantification in complex samples, minimizing matrix effects and ionization variability.

Basic Information

Product Name	n-Boc-n-Desethyl Sunitinib-D5
CAS No.	1246832-84-7
Molecular Formula	C26H30D5FN4O3
Molecular Weight	Contact for details
Synonyms	tert-Butyl (5-((5-fluoro-2-oxo-1,2-dihydro-3H-indol-3-ylidene)methyl)-2,4-dimethyl-1H-pyrrol-3-yl)((2-(diethyl-d5-amino)ethyl))carbamate; N-Boc-N-Desethyl Sunitinib-d5; Sunitinib N-Desethyl-d5 N-Boc; Sunitinib Impurity D5 N-Boc Derivative; Deuterated Sunitinib Intermediate; PF-00562271-d5 N-Boc Derivative; Isotopically Labeled Sunitinib Metabolite Standard
EINECS	Contact for details

Quality Control

Our n-Boc-n-Desethyl Sunitinib-D5 is manufactured under strict quality systems to ensure the high chemical and isotopic purity required for sensitive analytical applications. Each batch is characterized by advanced spectroscopic and chromatographic techniques, including NMR, HPLC, and mass spectrometry. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, isotopic enrichment (D5), and impurity profile. Our quality commitment aligns with the standards expected for GMP/GLP-compliant research.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 2-8°C. This compound is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	Off-white to light yellow solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D5)	≥ 98.0 atom % D
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C

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