Description

Crizotinib-D5 is a deuterated internal standard of the targeted cancer therapy agent Crizotinib, specifically designed for use in quantitative bioanalytical methods. This high-purity compound is essential for ensuring the accuracy and reliability of pharmacokinetic and metabolism studies in drug development. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities specializing in oncology research and therapeutic drug monitoring.

Application

• Primary use as an internal standard for LC-MS/MS analysis in bioanalytical method development and validation.
• Quantification of Crizotinib and its metabolites in biological matrices such as plasma, serum, and tissue homogenates.
• Supporting pharmacokinetic (PK) and pharmacodynamic (PD) studies during clinical trials for non-small cell lung cancer (NSCLC) and other ALK-positive cancers.
• Use in drug metabolism and disposition (DMPK) research to study absorption, distribution, metabolism, and excretion (ADME) profiles.
• Calibration and quality control in high-throughput therapeutic drug monitoring (TDM) programs.
• Reference material for forensic and clinical toxicology analysis.

Basic Information

Product Name	Crizotinib-D5
CAS No.	1395950-48-7
Molecular Formula	C21H17D5Cl2FN5O
Molecular Weight	450.36 g/mol
Synonyms	PF-02341066-d5; (R)-3-[1-(2,6-Dichloro-3-fluorophenyl)ethoxy]-5-[1-(piperidin-4-yl)-1H-pyrazol-4-yl]pyridin-2-amine-d5; Crizotinib (deuterated, D5); Crizotinib Internal Standard; Deuterated Crizotinib; Xalkori-d5 (deuterated analog)
EINECS	Contact for details

Quality Control

Our Crizotinib-D5 is manufactured under strict quality management systems to ensure the highest standards of purity and isotopic enrichment, critical for accurate mass spectrometry. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results for identity, chemical purity (HPLC), isotopic purity (D-content), and residual solvents. We support compliance with ICH Q7 and GMP guidelines for active pharmaceutical ingredient (API) starting materials.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity (D-content)	≥98 atom % D
Chemical Purity (by HPLC)	≥95.0%
Residual Solvents (GC)	Meets ICH limits
Water Content (KF)	≤1.0%

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