Description

n-Desethyl Sunitinib is a key pharmacologically active metabolite of the multi-targeted receptor tyrosine kinase inhibitor Sunitinib. This compound is of critical importance in pharmaceutical research and development, particularly for pharmacokinetic and metabolic profiling studies. It is primarily utilized by pharmaceutical companies, contract research organizations (CROs), and academic institutions engaged in oncology drug development and bioanalytical method validation.

Application

• Reference Standard for Bioanalysis: Serves as a certified reference material (CRM) for the quantification of Sunitinib and its metabolites in biological matrices (plasma, serum) using LC-MS/MS and HPLC methods.
• Pharmacokinetic (PK) and Metabolism Studies: Essential for investigating the absorption, distribution, metabolism, and excretion (ADME) profile of Sunitinib in preclinical and clinical research.
• Impurity Profiling and Characterization: Used as an identified impurity standard in the quality control of Sunitinib active pharmaceutical ingredient (API) to ensure drug purity and safety.
• Drug-Drug Interaction Research: Facilitates studies on how co-administered drugs affect the metabolic pathway of Sunitinib, crucial for clinical trial design.
• Metabolite Safety and Activity Assessment: Enables the evaluation of the individual pharmacological activity and toxicological profile of this major metabolite.
• Regulatory Submission Support: Provides essential data for regulatory filings (e.g., FDA, EMA) requiring comprehensive metabolite identification and quantification.

Basic Information

Product Name	n-Desethyl Sunitinib
CAS No.	356068-97-8
Molecular Formula	C₂₁H₂₇FN₄O₂
Molecular Weight	386.47 g/mol
Synonyms	Sunitinib N-Desethyl; N-Desethyl Sunitinib; SU12662; Sunitinib Metabolite N-Desethyl; PF-00272780 metabolite; (Z)-N-[2-(Diethylamino)ethyl]-5-[(5-fluoro-2-oxo-1H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide; 1H-Pyrrole-3-carboxamide, N-[2-(diethylamino)ethyl]-5-[(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl]-2,4-dimethyl-, (3Z)-; SU 12662
EINECS	Contact for details

Quality Control

Our n-Desethyl Sunitinib is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, LC-MS identification, and residual solvent analysis (ICH Q3C), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided for every shipment.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store at -20°C or below. Allow the product to equilibrate to room temperature in a dry environment before opening to minimize moisture uptake. The product should be stored in a dedicated freezer for pharmaceuticals.

Specification

Item	Specification
Appearance	Yellow to orange solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
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.