Description

Ceritinib Impurity 6 is a designated impurity of the targeted anticancer agent Ceritinib, identified by the CAS registry number 2173323-95-8. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical characterization and quality control of the active pharmaceutical ingredient (API). It is primarily required by analytical chemists, quality assurance professionals, and regulatory affairs specialists within the pharmaceutical and biotechnology industries to ensure drug purity, safety, and compliance with stringent regulatory guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Ceritinib Impurity 6 in drug substance and drug product testing.
• Method Development and Validation: Essential for developing and validating robust analytical methods, such as HPLC and LC-MS, for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure they remain within International Council for Harmonisation (ICH) specified limits.
• Stability Studies: Used to track the formation and growth of this specific impurity under various stress conditions (e.g., heat, humidity, light) to determine drug product shelf life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity understanding and control.
• Process Chemistry Research: Aids in understanding the formation pathway of this impurity during API synthesis, enabling process optimization to minimize its generation.

Basic Information

Product Name	Ceritinib Impurity 6
CAS No.	2173323-95-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	LDK378 Impurity 6; Zykadia Impurity 6; Ceritinib Related Compound 6; (2S)-1-[5-Bromo-4-[2-(isopropylsulfonyl)phenyl]pyrimidin-2-yl]-N-(5-chloro-2-fluorophenyl)piperidine-2-carboxamide; UNII-Contact for details
EINECS	Contact for details

Quality Control

Every batch of Ceritinib Impurity 6 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation, purity assessment, and impurity profiling via advanced chromatographic and spectroscopic techniques. Certificates of Analysis (COA) detailing batch-specific results are available upon request, supporting your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
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.