Description

Ponatinib-D8 is a deuterated isotopologue of the multi-targeted tyrosine kinase inhibitor Ponatinib, specifically labeled with eight deuterium atoms. This stable isotope-labeled compound is essential for use as an internal standard in quantitative bioanalytical methods, ensuring the highest accuracy and reliability in pharmacokinetic and metabolic studies. It is a critical tool for pharmaceutical R&D and clinical laboratories focused on oncology drug development and therapeutic drug monitoring.

Application

• Internal standard for the quantitative analysis of Ponatinib in biological matrices (e.g., plasma, serum) using LC-MS/MS.
• Use in pharmacokinetic (PK) and pharmacodynamic (PD) studies to ensure precise and accurate data.
• Metabolite identification and profiling studies in drug metabolism and disposition research.
• Supporting Good Laboratory Practice (GLP) and clinical trial bioanalysis for regulatory submissions.
• Method development and validation in analytical laboratories to meet FDA and EMA guidelines.
• Use as a reference material in quality control for the production of deuterated pharmaceutical compounds.

Basic Information

Product Name	Ponatinib-D8
CAS No.	1562993-37-6
Molecular Formula	C29H19D8F3N6O
Molecular Weight	532.60 g/mol
Synonyms	AP24534-D8; Iclusig-D8; 3-(Imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-[4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl]benzamide-D8; Ponatinib (D8); Deuterated Ponatinib; Ponatinib-d8 (octadeuterated)
EINECS	Contact for details

Quality Control

Our Ponatinib-D8 is manufactured under strict quality systems to ensure the highest isotopic purity and chemical integrity required for sensitive analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing parameters such as isotopic purity, chemical purity, and residual solvent content. We adhere to relevant industry standards to support our clients' regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C or as indicated on the label or COA. This product is hygroscopic (moisture-sensitive) and should be handled under dry conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity (D8)	≥98.0 atom % D
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Meets ICH guidelines

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