Description

Sunitinib Malate CAS NO 341031-54-7 is a small molecule, multi-targeted receptor tyrosine kinase (RTK) inhibitor. This compound is a critical active pharmaceutical ingredient (API) used in targeted cancer therapy. It is primarily required by pharmaceutical manufacturers and advanced research institutions for the development and production of oncology medications.

Application

• Pharmaceutical API: Primary active ingredient in the formulation of anti-cancer drugs.
• Oncology Treatment: Used in medications for gastrointestinal stromal tumors (GIST), advanced renal cell carcinoma (RCC), and pancreatic neuroendocrine tumors (pNET).
• Biomedical Research: A key reference standard and tool compound for studying tyrosine kinase signaling pathways and angiogenesis in cancer biology.
• Drug Development: Serves as a critical intermediate in the synthesis and process development of novel therapeutic agents.
• Clinical Research: Utilized in the preparation of clinical trial materials for investigational new drugs.

Basic Information

Product Name	Sunitinib Malate
CAS No.	341031-54-7
Molecular Formula	C22H27FN4O2 • C4H6O5
Molecular Weight	532.56 g/mol (for malate salt)
Synonyms	Sunitinib L-Malate; SU11248; SU 11248; Sutent (Brand Name); N-[2-(Diethylamino)ethyl]-5-[(Z)-(5-fluoro-2-oxo-1H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (2S)-2-hydroxybutanedioate; Sunitinib (S)-Malate; 5-[5-Fluoro-2-oxo-1,2-dihydro-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxylic acid (2-diethylaminoethyl)amide (2S)-2-hydroxybutanedioate
EINECS	Contact for details

Quality Control

Our Sunitinib Malate is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and potency meet stringent pharmaceutical standards. A comprehensive Certificate of Analysis (COA) detailing specifications such as assay, related substances, residual solvents, and heavy metals is provided with every shipment to guarantee traceability and compliance.

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 must be kept under inert conditions or in a desiccator to prevent degradation.

Specification

Item	Specification
Appearance	Yellow to orange powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Related Substances (HPLC)	Individual impurity: ≤ 0.5%; Total impurities: ≤ 2.0%
Heavy Metals	≤ 20 ppm

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