Description

Ensartinib Dihydrochloride is a highly potent and selective small-molecule inhibitor of anaplastic lymphoma kinase (ALK). This compound is a critical pharmaceutical intermediate and active pharmaceutical ingredient (API) used in the development of targeted cancer therapies. It is primarily required by pharmaceutical R&D laboratories, contract manufacturing organizations (CMOs), and biotechnology companies engaged in oncology drug development and production.

Application

• Pharmaceutical API Synthesis: Primary use as the active pharmaceutical ingredient in the formulation of targeted anti-cancer drugs.
• Oncology Research: A key reference standard and tool compound for in vitro and in vivo studies targeting ALK-positive non-small cell lung cancer (NSCLC) and other malignancies.
• Preclinical Development: Used in pharmacokinetics (PK), pharmacodynamics (PD), and toxicology studies during drug candidate screening and optimization.
• Clinical Trial Material (CTM) Manufacturing: Sourced for the production of batches used in Phase I-III clinical trials.
• Analytical Method Development: Serves as a high-purity standard for developing and validating HPLC, LC-MS, and other analytical methods.
• Process Chemistry & Scale-Up: Used by chemical engineers and process chemists to develop and optimize robust, scalable synthetic routes.

Basic Information

Product Name	Ensartinib Dihydrochloride
CAS No.	2137030-98-7
Molecular Formula	C27H32Cl2N8O2
Molecular Weight	571.50 g/mol
Synonyms	X-396 Dihydrochloride; Ensartinib HCl; X396 Dihydrochloride; NVP-X-396; (R)-Ensartinib Dihydrochloride; 1H-Pyrazolo[3,4-d]pyrimidine-6-carbonitrile, 4-[(3R)-3-piperidinyl]methoxy]-3-[4-[(4-[(1-piperazinyl)methyl]phenyl]amino]-3-pyridinyl]-, dihydrochloride
EINECS	Contact for details

Quality Control

Our Ensartinib Dihydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure identity, purity, and consistency, meeting the stringent requirements for pharmaceutical intermediates and APIs. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting results for assay, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 2-8°C. This product is hygroscopic (moisture-sensitive) and should be handled under inert atmosphere or in a controlled, low-humidity environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.0%
Purity (HPLC)	≥99.0%
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Heavy Metals	<20 ppm

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