Description

Pralsetinib is a potent and selective small-molecule inhibitor of the RET (Rearranged during Transfection) kinase, a key target in precision oncology. This high-purity active pharmaceutical ingredient (API) is critical for the development and manufacturing of targeted cancer therapies. It is primarily utilized by pharmaceutical companies and advanced research institutions focused on treating non-small cell lung cancer (NSCLC), medullary thyroid cancer, and other RET-altered solid tumors.

Application

• Active Pharmaceutical Ingredient (API) in the commercial manufacture of Pralsetinib capsules and other solid oral dosage forms.
• Key intermediate for research and development of next-generation RET kinase inhibitors.
• Reference standard for analytical method development and validation in quality control laboratories.
• Biochemical tool for in vitro pharmacological studies targeting RET-driven signaling pathways.
• Preclinical research material for investigating oncogenic mechanisms and combination therapies.
• GMP-grade material for clinical trial supply manufacturing.

Basic Information

Product Name	Pralsetinib
CAS No.	2097132-94-8
Molecular Formula	C₂₇H₃₂N₆O₃
Molecular Weight	488.59 g/mol
Synonyms	BLU-667; Pralsetinibum; N-(4-(6,7-Dimethoxyquinolin-4-yloxy)phenyl)-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide; GAVRETO (Brand Name); RET Kinase Inhibitor BLU-667; 1,1-Cyclopropanedicarboxamide, N-[4-[4-(6,7-dimethoxy-4-quinolinyl)oxy]phenyl]-N'-(4-fluorophenyl)-
EINECS	Contact for details

Quality Control

Our Pralsetinib is manufactured under strict quality systems to ensure it meets the rigorous standards required for pharmaceutical use. We provide comprehensive analytical data supporting identity, purity, and strength. Certificates of Analysis (COA) are available for each batch, detailing compliance with in-house specifications aligned with ICH Q3A/B guidelines. Our quality commitment includes traceability and documentation suitable for regulatory submissions.

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 under inert conditions or in a desiccator after opening 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)	≥98.5%
Related Substances (HPLC)	Total impurities ≤1.5% Any single unknown impurity ≤0.5%
Water Content (KF)	≤0.5%
Residue on Ignition	≤0.1%
Heavy Metals	≤20 ppm

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