Description

Alectinib Impurity 10 is a designated impurity of the active pharmaceutical ingredient Alectinib, a targeted therapy used in oncology. This high-purity reference standard is critical for pharmaceutical research, development, and quality control processes, ensuring the safety and efficacy of the final drug product. It is primarily utilized by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Alectinib drug substance and drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity levels.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Alectinib batches meet stringent purity specifications per ICH guidelines.
• Stability Studies: Employed to identify and quantify degradation products that may form under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Process Chemistry Research: Aids in understanding the formation pathway of this impurity during the synthesis of Alectinib, helping to optimize manufacturing processes.

Basic Information

Product Name	Alectinib Impurity 10
CAS No.	1256584-81-2
Molecular Formula	C30H34N4O2
Molecular Weight	482.62 g/mol
Synonyms	9-Ethyl-6,6-dimethyl-8-[4-(morpholin-4-yl)piperidin-1-yl]-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile; Alectinib Related Compound 10; Alectinib Impurity B; ALK Inhibitor Impurity; UNII-Contact for details
EINECS	Contact for details

Quality Control

Every batch of Alectinib Impurity 10 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC, MS, NMR) to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); ensure the container is kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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