Description

Ponatinib Hydrochloride is a potent, orally active multi-targeted tyrosine kinase inhibitor. This high-purity active pharmaceutical ingredient (API) is critical for advanced pharmaceutical research and development targeting specific oncogenic pathways. It is primarily utilized by pharmaceutical companies and research institutions engaged in the development of novel cancer therapeutics, particularly for resistant forms of leukemia.

Application

• Pharmaceutical API: Serves as the active ingredient in the formulation of finished dosage forms for clinical and commercial use.
• Oncology Research: A key tool in preclinical and clinical studies investigating treatments for chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).
• Reference Standard: Used as a certified reference material in analytical laboratories for quality control and method validation.
• Biochemical Assay Development: Employed in high-throughput screening and enzymatic assays to study kinase inhibition and signal transduction pathways.
• Drug Discovery & Development: Integral to medicinal chemistry programs aimed at developing next-generation kinase inhibitors.

Basic Information

Product Name	Ponatinib Hydrochloride
CAS No.	1114544-31-8
Molecular Formula	C29H28ClFN8O•HCl
Molecular Weight	569.95 g/mol
Synonyms	AP24534; Iclusig (brand name); Ponatinib HCl; 3-(2-Imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-[4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl]benzamide hydrochloride; Benzamide, 3-(2-imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-[4-[(4-methyl-1-piperazinyl)methyl]-3-(trifluoromethyl)phenyl]-, hydrochloride (1:1)
EINECS	Contact for details

Quality Control

Our Ponatinib Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure identity, purity, and strength, meeting stringent specifications for pharmaceutical use. A Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and other critical parameters is provided with every shipment to ensure full traceability and regulatory compliance.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Residue on Ignition	≤ 0.1%

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