Description

N,n-Didesethyl Sunitinib-D4 Hydrochloride is a high-purity, deuterated internal standard critical for accurate quantitative analysis in bioanalytical and pharmacokinetic studies. This compound is specifically designed for use in Liquid Chromatography-Mass Spectrometry (LC-MS) applications, where it serves as a stable isotope-labeled reference to ensure precision and reliability in data. It is an essential tool for pharmaceutical R&D laboratories, contract research organizations (CROs), and quality control units involved in the development and validation of assays for sunitinib and its metabolites.

Application

• LC-MS/MS Internal Standard: Primary use as a deuterium-labeled internal standard for the precise quantification of sunitinib and its metabolites in biological matrices (e.g., plasma, serum, tissue homogenates).
• Pharmacokinetic & Bioanalytical Research: Enables accurate measurement of drug concentration-time profiles, supporting ADME (Absorption, Distribution, Metabolism, Excretion) studies and clinical trial sample analysis.
• Method Development & Validation: Critical for developing and validating robust, GLP-compliant analytical methods in pharmaceutical R&D and quality control laboratories.
• Metabolite Profiling: Aids in the identification and quantification of specific metabolic pathways of sunitinib, facilitating drug metabolism and safety studies.
• Reference Material for QC: Serves as a certified reference material to ensure the accuracy and consistency of analytical results across batches and laboratories.

Basic Information

Product Name	N,n-Didesethyl Sunitinib-D4 Hydrochloride
CAS No.	1346606-30-1
Molecular Formula	C20H19D4FN4O2 • HCl
Molecular Weight	422.91 g/mol (free base: 387.48)
Synonyms	N-Desethyl Sunitinib D4 Metabolite; N,N-Didesethyl Sunitinib-d4 HCl; Sunitinib N,N-Didesethyl Metabolite-d4 Hydrochloride; SU11248 N,N-Didesethyl-d4; 5-[5-Fluoro-2-oxo-1,2-dihydro-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxylic acid (2-diethylamino-d4)ethyl ester hydrochloride
EINECS	Contact for details

Quality Control

Every batch of N,n-Didesethyl Sunitinib-D4 Hydrochloride is manufactured and analyzed under strict quality management systems. We provide comprehensive Certificates of Analysis (COA) detailing purity, isotopic enrichment, and impurity profiles, ensuring compliance with the stringent requirements for analytical reference standards. Our quality protocols are designed to meet the needs of GLP and cGMP environments, supporting reliable and reproducible scientific outcomes.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry, cool place. This compound is hygroscopic (moisture-sensitive); ensure containers are sealed under inert atmosphere or with desiccant to maintain stability and purity upon long-term storage.

Specification

Item	Specification
Appearance	Yellow to orange solid
Identification (HPLC-MS)	Conforms
Identification (NMR)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Enrichment (D4)	≥ 98.0 atom % D
Chemical Purity (by HPLC)	≥ 95.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.5%

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