Description

Ponatinib Tris-Hydrochloride is a potent and selective multi-targeted tyrosine kinase inhibitor, supplied as the tris-hydrochloride salt for enhanced stability and handling. This high-purity active pharmaceutical ingredient (API) is critical for pharmaceutical research, development, and manufacturing, particularly in the field of oncology. It is essential for researchers and manufacturers developing targeted therapies for specific hematologic malignancies and solid tumors.

Application

• Pharmaceutical API: Serves as the active ingredient in the formulation of finished dosage forms for targeted cancer therapy.
• Oncology Research: Used as a critical reference standard and biochemical tool in preclinical studies to investigate mechanisms of tyrosine kinase inhibition.
• Drug Development: Employed in the synthesis and process development of novel therapeutic agents targeting BCR-ABL and other kinases.
• Bioassay & Screening: Utilized in high-throughput screening (HTS) and cell-based assays to evaluate drug efficacy and resistance mechanisms.
• Clinical Trial Material (CTM): Supplied as a key component for the production of clinical trial supplies under GMP guidelines.
• Academic Research: Supports fundamental research in molecular biology and signal transduction pathways related to cancer.

Basic Information

Product Name	Ponatinib Tris-Hydrochloride
CAS No.	1232836-25-7
Molecular Formula	C29H27F3N6O • 3HCl
Molecular Weight	667.94 g/mol (Free base: 532.57)
Synonyms	AP24534 Tris-Hydrochloride; Iclusig (API form); Ponatinib HCl (3:1); 3-(Imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-[4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl]benzamide tris-hydrochloride; AP-24534 Tris-HCl; Ponatinib trihydrochloride
EINECS	Contact for details

Quality Control

Our Ponatinib Tris-Hydrochloride is manufactured and tested to meet stringent quality standards suitable for pharmaceutical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We ensure compliance with relevant ICH guidelines and can support development under current Good Manufacturing Practice (cGMP) standards for advanced clinical stages.

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. The material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Assay (HPLC)	≥98.0% (on anhydrous basis)
Water Content (KF)	≤5.0%
Residue on Ignition	≤0.5%
Heavy Metals	≤20 ppm
Related Substances (HPLC)	Individual impurity: ≤0.5%; Total impurities: ≤2.0%
Residual Solvents (GC)	Complies with ICH Q3C

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