Description

Alectinib M4 Metabolite CAS NO 1256585-04-2 is a key pharmacologically active metabolite of the targeted therapy drug Alectinib, used in the treatment of ALK-positive non-small cell lung cancer (NSCLC). This compound is critical for pharmaceutical research and development, particularly in the areas of drug metabolism and pharmacokinetics (DMPK) studies, bioanalytical method development, and impurity profiling. It serves as an essential reference standard for laboratories in the pharmaceutical, biotechnology, and contract research organization (CRO) sectors, ensuring the accuracy and regulatory compliance of analytical data for both drug development and quality control processes.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the quantitative and qualitative analysis of Alectinib and its metabolites in biological matrices and drug products.
• Drug Metabolism & Pharmacokinetics (DMPK): Essential for in vitro and in vivo studies to understand the metabolic pathways, clearance, and exposure of Alectinib.
• Bioanalytical Method Development & Validation: Used to develop, calibrate, and validate LC-MS/MS and HPLC methods for therapeutic drug monitoring and clinical trials.
• Impurity Profiling & Control: Acts as a specified impurity standard to monitor and control the quality of Alectinib active pharmaceutical ingredient (API) and finished dosage forms according to ICH guidelines.
• Preclinical & Clinical Research: Supports non-clinical safety assessments and clinical pharmacology studies to establish safety and efficacy profiles.
• Regulatory Submissions: Provides critical data for filings with regulatory bodies (e.g., FDA, EMA) to demonstrate understanding of the drug's metabolic fate.

Basic Information

Product Name	Alectinib M4 Metabolite
CAS No.	1256585-04-2
Molecular Formula	C30H34N4O2
Molecular Weight	482.62 g/mol
Synonyms	PF-06463922 M4 Metabolite; Alectinib Metabolite M4; N-{3-[(5-Chloro-2-{[(1R,4R)-4-(4-methylpiperazin-1-yl)cyclohexyl]amino}pyrimidin-4-yl)amino]phenyl}acrylamide; (R)-N-(3-(5-Chloro-2-((4-(4-methylpiperazin-1-yl)cyclohexyl)amino)pyrimidin-4-ylamino)phenyl)acrylamide; Alectinib Carboxylic Acid Metabolite; Alecensa Metabolite M4; CH5424802 Metabolite M4
EINECS	Contact for details

Quality Control

Our Alectinib M4 Metabolite is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity analysis, LC-MS identity confirmation, and residual solvent screening to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) containing batch-specific data is provided with every shipment. Our quality commitment aligns with the principles of current Good Manufacturing Practice (cGMP) for APIs and ICH Q3A/B guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a freezer. This product is hygroscopic (moisture-sensitive). Allow the sealed vial to equilibrate to room temperature before opening to minimize moisture uptake. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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