Description

n-Desethylsunitinib Hydrochloride is a key pharmaceutical intermediate and metabolite of the oncology drug Sunitinib. This compound is of significant value for research and development in the pharmaceutical industry, particularly for metabolic studies, bioanalytical method development, and as a reference standard. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and manufacturers of active pharmaceutical ingredients (APIs) and high-purity reference materials.

Application

• Primary use as a pharmaceutical reference standard for analytical method development and validation.
• Critical metabolite standard in pharmacokinetic and bioequivalence studies of Sunitinib.
• Key research chemical for investigating the metabolic pathways and disposition of tyrosine kinase inhibitors.
• Essential intermediate in the synthesis and impurity profiling of Sunitinib malate API.
• Used in quality control laboratories for the identification and quantification of related substances.
• Valuable material for academic and institutional research focused on cancer therapeutics.

Basic Information

Product Name	n-Desethylsunitinib Hydrochloride
CAS No.	1261432-05-6
Molecular Formula	C₂₁H₂₇FN₄O₂ • HCl
Molecular Weight	422.92 g/mol (Free base: 386.47 g/mol)
Synonyms	N-Desethyl Sunitinib Hydrochloride; Desethyl Sunitinib HCl; SU12662 Hydrochloride; Sunitinib Metabolite N-Desethyl Hydrochloride; N-Desethyl Sunitinib; 5-[5-Fluoro-2-oxo-1,2-dihydro-3H-indol-3-ylidenemethyl]-2,4-dimethyl-1H-pyrrole-3-carboxylic acid (2-diethylaminoethyl)amide hydrochloride; PF-00562271 hydrochloride
EINECS	Contact for details

Quality Control

Our n-Desethylsunitinib Hydrochloride is manufactured under strict quality systems to ensure high purity and consistency, suitable for research and analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We adhere to relevant ICH guidelines for stability and impurity characterization to meet the stringent requirements of pharmaceutical development.

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 material 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 (IR)	Conforms to structure
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 98.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.2%
Heavy Metals	≤ 20 ppm

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