Description

Alectinib-D8 is a deuterated internal standard of the targeted therapy alectinib, specifically designed for analytical and research applications. This high-purity compound is essential for ensuring the accuracy and reliability of quantitative analysis in pharmacokinetic and bioanalytical studies. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and quality control departments for method development and validation.

Application

• Bioanalytical Method Development: Serves as a critical internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the precise quantification of alectinib in biological matrices like plasma and serum.
• Pharmacokinetic (PK) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles in clinical and preclinical research.
• Drug Metabolism Research: Used in metabolite identification and profiling studies to understand the metabolic pathways of alectinib.
• Quality Control & Assurance: Employed in pharmaceutical manufacturing for in-process testing and final product release to ensure batch consistency and potency.
• Clinical Trial Support: Provides reliable data for therapeutic drug monitoring (TDM) and patient stratification in oncology clinical trials.
• Regulatory Submissions: Supports the generation of robust, GLP-compliant data required for regulatory filings with agencies like the FDA and EMA.

Basic Information

Product Name	Alectinib-D8
CAS No.	1256585-15-5
Molecular Formula	C30H26D8N4O2
Molecular Weight	486.67 g/mol
Synonyms	9-Ethyl-6,11-dihydro-6,6,8,8,9,11,11,11-octadeutero-5,11-dihydro-8-[4-(4-methyl-1-piperazinyl)-1-piperidinyl]-5-oxo-4H-pyrido[2,3-b][1,4]benzodiazepine-3-carbonitrile; Alectinib (hexadeutero, phenyl-d8); CH5424802-D8; Alecensa-D8; Deuterated Alectinib; Alectinib-d8 Internal Standard
EINECS	Contact for details

Quality Control

Every batch of Alectinib-D8 is manufactured under strict quality management systems and undergoes comprehensive analytical testing. We guarantee high chemical purity and isotopic enrichment suitable for sensitive analytical applications. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming identity, purity (by HPLC), and deuterium content. Our quality protocols are designed to support research requiring GMP/GLP compliance.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry, cool place. This product is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability and purity. Allow the vial to equilibrate to room temperature before opening to minimize moisture condensation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥98.0%
Chemical Purity (HPLC)	≥99.0%
Deuterium Enrichment	≥98 atom % D
Water Content (KF)	≤0.5%
Residual Solvents (GC)	Meets ICH guidelines

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