Description

Alectinib Hydrochloride CAS NO 1256589-74-8 is a high-purity, small molecule pharmaceutical active ingredient classified as a potent and selective anaplastic lymphoma kinase (ALK) inhibitor. This compound is of critical importance for the research, development, and production of targeted cancer therapies, particularly for non-small cell lung cancer (NSCLC). It is primarily required by pharmaceutical manufacturers, advanced research institutions, and contract development and manufacturing organizations (CDMOs) engaged in oncology drug formulation.

Application

• Active Pharmaceutical Ingredient (API) for the manufacture of targeted oral oncology medications.
• Reference Standard for analytical method development and validation in quality control laboratories.
• Biochemical Research for studying ALK signaling pathways and mechanisms of drug resistance.
• Preclinical and Clinical Trial Material for pharmacokinetic and pharmacodynamic studies.
• Formulation Development for creating various dosage forms such as tablets or capsules.
• Impurity Profiling, serving as a primary standard to identify and quantify related substances.

Basic Information

Product Name	Alectinib Hydrochloride
CAS No.	1256589-74-8
Molecular Formula	C30H35ClN4O2
Molecular Weight	519.08 g/mol
Synonyms	Alectinib HCl; CH5424802 Hydrochloride; 9-Ethyl-6,11-dihydro-6,6-dimethyl-8-[4-(4-morpholinyl)-1-piperidinyl]-11-oxo-5H-benzo[b]carbazole-3-carbonitrile Hydrochloride; Alecensa (brand name salt form); AF-802 Hydrochloride; RG-7853 Hydrochloride
EINECS	Contact for details

Quality Control

Our Alectinib Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, aligning with ICH guidelines. A detailed Certificate of Analysis (COA) documenting results for assay, related substances, residual solvents, and other critical parameters is provided with every shipment to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-30°C (59-86°F). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants and inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Specific Rotation	Contact for details

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