Description

Radotinib Dihydrochloride is a high-purity, small-molecule active pharmaceutical ingredient (API) belonging to the class of tyrosine kinase inhibitors. This compound is critical for pharmaceutical research and development, particularly in the field of oncology. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and academic research institutions focused on developing novel therapeutic agents for cancer treatment.

Application

• Pharmaceutical API Intermediate: Serves as a key raw material in the synthesis and formulation of finished drug products.
• Oncology Research: Used as a reference standard and active compound in preclinical and clinical research targeting specific kinase pathways.
• Biochemical Assay Development: Employed in high-throughput screening (HTS) and in-vitro studies to evaluate potency and mechanism of action.
• Drug Discovery Programs: A vital component in medicinal chemistry for structure-activity relationship (SAR) studies and lead optimization.
• GMP Manufacturing: Supplied under controlled conditions for use in Good Manufacturing Practice (GMP) compliant production of investigational or commercial drugs.

Basic Information

Product Name	Radotinib Dihydrochloride
CAS No.	926037-85-6
Molecular Formula	C29H31Cl2N7O
Molecular Weight	564.51 g/mol
Synonyms	Radotinib HCl; IY-5511 dihydrochloride; Supect; 4-Methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]benzamide dihydrochloride; Radotinib hydrochloride; UNII-6KQ3E6S2F1
EINECS	Contact for details

Quality Control

Our Radotinib Dihydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, residual solvent analysis, and identification by spectroscopic methods, to ensure it meets stringent pharmaceutical-grade specifications. Certificates of Analysis (COA) with detailed batch-specific results are provided and can be tailored to support regulatory filings (e.g., DMF, CMC sections).

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 material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.0%
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.1%
Heavy Metals	≤20 ppm
Related Substances (HPLC)	Total impurities ≤2.0%; Any single impurity ≤0.5%

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