Description

Ceritinib D7 is a deuterated analog of the targeted oncology agent Ceritinib, specifically labeled with seven deuterium atoms. This stable isotope-labeled compound is an essential internal standard for the precise quantification of Ceritinib in biological matrices using advanced analytical techniques like LC-MS/MS. It is a critical tool for pharmaceutical R&D and clinical laboratories engaged in pharmacokinetic studies, drug metabolism research, and bioanalytical method development. The use of this high-purity standard ensures accurate and reliable data, supporting drug development and regulatory compliance.

Application

• Bioanalytical Internal Standard: Primary use as a stable isotope-labeled internal standard for the accurate quantification of Ceritinib in plasma, serum, and tissue samples via mass spectrometry.
• Pharmacokinetic & Metabolism Studies: Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• LC-MS/MS Method Development & Validation: Serves as a critical reference material for developing, optimizing, and validating sensitive and specific bioanalytical assays.
• Drug Impurity Profiling: Used in comparative analysis to identify and characterize potential deuterated impurities or metabolites in drug substances.
• Clinical Research & Therapeutic Drug Monitoring (TDM): Supports studies aimed at understanding exposure-response relationships and optimizing dosing regimens for ALK-positive non-small cell lung cancer (NSCLC) patients.
• Regulatory Submissions: Provides essential data traceability and accuracy required for filings with regulatory bodies such as the FDA and EMA.

Basic Information

Product Name	Ceritinib D7
CAS No.	1632484-77-5
Molecular Formula	C28H29D7ClN5O3S
Molecular Weight	~ 564.2 g/mol
Synonyms	LDK378 D7; NVP-LDK378 D7; Zykadia D7; 5-Chloro-N4-[2-[(1-methylethyl)sulfonyl]phenyl]-N2-[5-methyl-2-(1-methylethoxy)-4-(piperidin-4-yl)phenyl]-2,4-pyrimidinediamine-d7; LDK-378 D7; Ceritinib (heptadeuterated); Ceritinib-d7
EINECS	Contact for details

Quality Control

Our Ceritinib D7 is manufactured under strict quality control protocols to ensure the highest standards of isotopic purity and chemical integrity. Each batch is characterized by advanced spectroscopic and chromatographic methods, including NMR, HPLC, and MS. A comprehensive Certificate of Analysis (COA) is provided, detailing isotopic enrichment (D7, typically >98%), chemical purity (typically >98% by HPLC), and analytical data. We support compliance with GMP/GLP guidelines for research use.

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) and should be handled under anhydrous conditions to maintain stability. Allow the vial to equilibrate to room temperature in a desiccator before opening to prevent condensation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D7)	≥ 98 atom % D
Chemical Purity (NMR)	Conforms
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Meets ICH guidelines

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