Description

n-Desethyl Sunitinib-D5 is a high-purity, deuterium-labeled internal standard critical for accurate quantitative analysis in bioanalytical and pharmacokinetic studies. This compound is essential for ensuring the precision and reliability of mass spectrometry-based assays by correcting for variations in sample preparation and instrument response. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers specializing in oncology drug development and metabolite profiling.

Application

• Internal Standard for LC-MS/MS: Serves as a critical reference compound for the precise quantification of Sunitinib and its metabolites in complex biological matrices such as plasma, serum, and tissue homogenates.
• Pharmacokinetic (PK) and Toxicokinetic (TK) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles in preclinical and clinical research.
• Metabolite Identification and Profiling: Used as a stable isotope-labeled tracer to identify and quantify the desethyl metabolite pathway of Sunitinib, aiding in understanding its biotransformation.
• Bioanalytical Method Development and Validation: A key component in developing robust, regulatory-compliant (FDA/EMA) analytical methods for drug monitoring and bioequivalence studies.
• Quality Control in Drug Manufacturing: Supports impurity profiling and stability testing of Sunitinib active pharmaceutical ingredient (API) and related drug products.

Basic Information

Item	Details
Product Name	n-Desethyl Sunitinib-D5
CAS No.	1217247-62-5
Molecular Formula	C₂₁H₂₂D₅FN₄O₂
Molecular Weight	Contact for details
Synonyms	N-Desethyl Sunitinib-d5; Sunitinib N-Desethyl Metabolite-d5; PF-00299804 Desethyl Metabolite-d5; (Z)-N-[2-(Diethylamino)ethyl]-5-[(5-fluoro-2-oxo-1,2-dihydro-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide-d5; SU11248 Desethyl-d5; 3-[(Z)-(2,4-Dimethyl-5-((2-(diethyl-d5-amino)ethyl)carbamoyl)-1H-pyrrol-3-yl)methylene]-5-fluoroindolin-2-one
EINECS	Contact for details

Quality Control

Every batch of n-Desethyl Sunitinib-D5 is manufactured under strict quality management systems and undergoes comprehensive analytical characterization to ensure identity, purity, and isotopic enrichment. Certificates of Analysis (COA) are provided, detailing results from advanced techniques including NMR, HPLC, and mass spectrometry to confirm compliance with stringent specifications for use as an internal standard.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry, cool place. This product is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability and purity. Allow the vial to equilibrate to room temperature in a desiccator before opening to prevent condensation.

Specification

Item	Specification
Appearance	Off-white to light yellow solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-content)	≥ 98.0 atom % D
Chemical Purity	≥ 95.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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