Description

n-Desethyl Sunitinib Malate is a key pharmaceutical intermediate and metabolite of the multi-targeted receptor tyrosine kinase inhibitor Sunitinib. This compound is of critical importance for research and development in the fields of oncology and pharmacokinetics, serving as a vital reference standard for analytical studies. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and academic institutions focused on cancer therapeutics and drug metabolism.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantification and qualification of Sunitinib and its metabolites in biological matrices.
• Drug Metabolism & Pharmacokinetics (DMPK) Studies: Essential for investigating the metabolic pathways, bioavailability, and clearance rates of Sunitinib in preclinical and clinical research.
• Analytical Method Development: Serves as a critical component in developing and validating HPLC, LC-MS, and other chromatographic methods for impurity profiling and assay determination.
• Impurity Characterization: Employed to identify, monitor, and control process-related impurities and degradation products in Sunitinib Malate active pharmaceutical ingredient (API) manufacturing.
• Bioanalytical Research: Used in studies to understand the pharmacodynamic and toxicological profiles associated with Sunitinib's metabolites.

Basic Information

Product Name	n-Desethyl Sunitinib Malate
CAS No.	1474111-36-8
Molecular Formula	C₂₁H₂₇FN₄O₂ • C₄H₆O₅
Molecular Weight	532.55 g/mol
Synonyms	N-Desethyl Sunitinib Malate; PF-00299804 N-Desethyl Malate; Sunitinib N-Desethyl Metabolite Malate; (Z)-N-[2-(Diethylamino)ethyl]-5-[(5-fluoro-2-oxo-1H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (S)-2-Hydroxybutanedioate; SU11248 Metabolite Malate
EINECS	Contact for details

Quality Control

Our n-Desethyl Sunitinib Malate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a detailed Certificate of Analysis (COA) with each shipment, ensuring traceability and compliance with research-grade standards. Specifications are designed to meet the rigorous demands of pharmaceutical reference material applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	Yellow to orange solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Meets ICH guidelines

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