Description

N,n-Didesethyl Sunitinib Hydrochloride is a key pharmaceutical intermediate and metabolite of the oncology drug Sunitinib. This compound is of critical importance for research and development in the pharmaceutical industry, particularly for metabolic studies, impurity profiling, and the synthesis of novel therapeutic agents. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and manufacturers specializing in active pharmaceutical ingredients (APIs) and high-purity reference standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of Sunitinib and its metabolites in drug substance and product testing.
• Metabolite Research: Essential for in-vitro and in-vivo metabolic pathway studies to understand the pharmacokinetics and pharmacodynamics of Sunitinib.
• Impurity Profiling: Serves as a specified impurity standard in the quality control of Sunitinib malate API, ensuring compliance with ICH guidelines on impurities in new drug substances.
• Analytical Method Development: Employed in the development and validation of HPLC, LC-MS, and other chromatographic methods for biomarker and bioanalytical assays.
• Preclinical & Clinical Studies: Used in toxicology and clinical trial sample analysis to monitor metabolite levels and assess drug safety profiles.
• Chemical Synthesis Intermediate: Acts as a building block for the synthesis of novel Sunitinib analogs and related tyrosine kinase inhibitors for research purposes.

Basic Information

Product Name	N,n-Didesethyl Sunitinib Hydrochloride
CAS No.	873077-70-4
Molecular Formula	C20H21FN4O2 • HCl
Molecular Weight	412.87 g/mol (Free base: 376.41 g/mol)
Synonyms	Sunitinib N-Desethyl Metabolite; N-Desethyl Sunitinib Hydrochloride; PF-00518700; SU12662 Metabolite; N-Desethyl Sunitinib HCl; 5-[5-Fluoro-2-oxo-1,2-dihydro-3H-indol-3-ylidenemethyl]-2,4-dimethyl-1H-pyrrole-3-carboxylic Acid (2-Diethylaminoethyl)amide Hydrochloride; N-Desethyl Sunitinib; Sunitinib Impurity F (Hydrochloride)
EINECS	Contact for details

Quality Control

Our N,n-Didesethyl Sunitinib Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, LC-MS for identity confirmation, and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical research. Certificates of Analysis (COA) with detailed chromatographic data are provided and traceable to in-house reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	Yellow to orange solid
Identification (HPLC)	Conforms to reference standard
Identification (Mass Spectrometry)	Conforms
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	< 20 ppm

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