Description

Afatinib-D6 is a deuterium-labeled internal standard of the tyrosine kinase inhibitor Afatinib, essential for ensuring accuracy and reliability in quantitative bioanalytical studies. This high-purity compound is critical for pharmaceutical research and development, particularly in pharmacokinetic and metabolic studies where precise measurement is paramount. It is primarily used by analytical laboratories, CROs, and pharmaceutical companies engaged in the development and quality control of oncology therapeutics.

Application

• Internal Standard for LC-MS/MS quantification of Afatinib in biological matrices (plasma, serum, tissue).
• Use in pharmacokinetic (PK) and pharmacodynamic (PD) studies during drug development.
• Metabolite identification and profiling in mass spectrometry-based assays.
• Method development and validation for regulatory bioanalysis (FDA, EMA).
• Quality control and assurance in clinical trial sample analysis.
• Stability studies and degradation pathway analysis.

Basic Information

Product Name	Afatinib-D6
CAS No.	1313874-96-2
Molecular Formula	C24H19D6ClFN5O3
Molecular Weight	486.98 g/mol
Synonyms	Afatinib-d6; BIBW 2992-D6; (2E)-N-[4-(3-Chloro-4-fluorophenyl)amino]-7-{[(3S)-oxolan-3-yl]oxy}quinazolin-6-yl]-4-(dimethylamino)but-2-enamide-d6; Gilotrif-D6; Giotrif-D6; Tovok-D6; Deuterated Afatinib
EINECS	Contact for details

Quality Control

Our Afatinib-D6 is manufactured under strict quality control protocols to ensure the highest standards of purity and isotopic enrichment, suitable for sensitive analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results from NMR, HPLC, and MS analysis. We adhere to cGMP guidelines for the production of reference standards, ensuring traceability and consistency for regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below. This product is hygroscopic (moisture-sensitive) and should be handled under inert atmosphere or in a controlled, dry environment to maintain stability and purity. Allow the vial to equilibrate to room temperature in a desiccator before opening.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (NMR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Chemical Purity	≥95.0%
Isotopic Enrichment	≥98.0 atom % D
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.