Description

Ensartinib (X-396) is a potent, selective, and orally bioavailable small-molecule inhibitor of anaplastic lymphoma kinase (ALK). This compound matters as a key pharmaceutical intermediate and reference standard in the research and development of targeted cancer therapies, particularly for non-small cell lung cancer (NSCLC). It is needed by pharmaceutical R&D laboratories, contract research organizations (CROs), and academic institutions focused on oncology drug discovery and clinical studies.

Application

• Pharmaceutical Intermediate: Serves as a critical building block in the synthesis of advanced investigational drugs targeting ALK-positive cancers.
• Reference Standard: Used for analytical method development, validation, and quality control in pharmaceutical manufacturing and regulatory submissions.
• Biochemical Research: Employed in in vitro studies to investigate ALK signaling pathways, kinase selectivity profiles, and mechanisms of drug resistance.
• Preclinical Development: Utilized in pharmacokinetic (PK), pharmacodynamic (PD), and toxicology studies to support Investigational New Drug (IND) applications.
• Clinical Trial Material (CTM): Supplied as a high-purity active pharmaceutical ingredient (API) for the formulation of drugs used in clinical trials.

Basic Information

Product Name	Ensartinib (X-396)
CAS No.	1370651-20-9
Molecular Formula	C₂₇H₃₂ClN₅O₃
Molecular Weight	510.03 g/mol
Synonyms	X-396; X396; Ensartinib; (R)-11-(4-(4-(2-((2-Chloro-4-((2-(dimethylamino)ethyl)(methyl)amino)phenyl)amino)-5-methylpyrimidin-4-yl)piperazin-1-yl)piperidin-1-yl)-12-ethyl-4-hydroxy-1,11-dioxo-2,3,4,10-tetrahydro-1H-1,10,4a-triazadibenzo[cd,f]azulen-8(11H)-one; UNII-9Q0B7F8F5P
EINECS	Contact for details

Quality Control

Our Ensartinib (X-396) is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency, meeting the stringent requirements for pharmaceutical research and development. Certificates of Analysis (COA) with detailed HPLC chromatograms and impurity profiles are provided to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Assay (HPLC)	≥98.0%
Purity (HPLC, Area%)	≥99.0%
Single Unknown Impurity	≤0.5%
Total Impurities	≤1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤0.5%
Heavy Metals	≤20 ppm

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