Description

Alectinib Impurity CAS NO 1256584-83-4 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Alectinib, a targeted therapy used in oncology. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of this well-characterized impurity is essential for meeting stringent regulatory compliance in drug development and manufacturing.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Alectinib API and finished drug products.
• Critical component in analytical method development and validation (HPLC, LC-MS) for stability-indicating assays.
• Essential for conducting stability studies and forced degradation studies to understand the degradation pathways of Alectinib.
• Used in quality control (QC) and quality assurance (QA) laboratories to establish impurity profiles and release specifications.
• Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Valuable for academic and clinical research investigating the metabolism and pharmacokinetics of Alectinib.
• Serves as a starting material or intermediate for the synthesis of related compounds in medicinal chemistry research.

Basic Information

Product Name	Alectinib Impurity
CAS No.	1256584-83-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Alectinib Related Compound; Alectinib Impurity Standard; Alectinib Process Impurity; ALK Inhibitor Impurity; 9-Ethyl-6,6-dimethyl-8-[4-(morpholin-4-yl)piperidin-1-yl]-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile Impurity; 1256584-83-4; Alectinib Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Alectinib Impurity CAS NO 1256584-83-4 is manufactured and handled under strict quality management systems. Our products undergo rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B guidelines and other relevant pharmacopeial standards for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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