Description

Alectinib is a highly potent and selective anaplastic lymphoma kinase (ALK) inhibitor used as an active pharmaceutical ingredient (API). This compound is critical for the formulation of targeted cancer therapies, specifically for the treatment of ALK-positive non-small cell lung cancer (NSCLC). It is essential for pharmaceutical manufacturers and research institutions engaged in oncology drug development and production.

Application

• Pharmaceutical API: Primary use as the active ingredient in finished dosage forms for the treatment of ALK-positive metastatic non-small cell lung cancer.
• Oncology Research: A key reference standard and biochemical tool for studying ALK signaling pathways and resistance mechanisms in cancer cell lines.
• Drug Development: Serves as a critical intermediate or reference compound in the R&D of next-generation ALK inhibitors and combination therapies.
• Clinical Trial Materials: Used in the manufacturing of investigational medicinal products for Phase I-III clinical studies.
• Generic Drug Manufacturing: Sourced by generic pharmaceutical companies for the production of bioequivalent versions following patent expiry.

Basic Information

Product Name	Alectinib
CAS No.	1256580-46-7
Molecular Formula	C30H34N4O2
Molecular Weight	482.62 g/mol
Synonyms	CH5424802; Alecensa (Brand Name); 9-Ethyl-6,6-dimethyl-8-[4-(morpholin-4-yl)piperidin-1-yl]-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile; AF-802; RG-7853; Alectinib Hydrochloride (Salt Form); ALK Inhibitor CH5424802
EINECS	Contact for details

Quality Control

Our Alectinib is manufactured under cGMP conditions, ensuring the highest standards of purity and consistency for pharmaceutical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profiles. We adhere to stringent ICH guidelines for stability and validation, providing full traceability and regulatory support documentation.

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 to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Assay (HPLC)	≥ 98.5%
Related Substances (HPLC)	Total impurities ≤ 1.0%
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.