Description

Intedanib-D8 is a deuterated isotopologue of the tyrosine kinase inhibitor Intedanib, specifically labeled with eight deuterium atoms. This stable isotope-labeled compound is a critical reference standard and internal standard for the precise quantification and pharmacokinetic studies of Intedanib in complex biological matrices using advanced analytical techniques like LC-MS/MS. It is an essential tool for pharmaceutical R&D, clinical research, and bioanalytical laboratories focused on oncology drug development and therapeutic monitoring.

Application

• Bioanalytical Reference Standard: Primary use as an internal standard for the accurate quantification of Intedanib in plasma, serum, and tissue samples via mass spectrometry.
• Pharmacokinetic and Metabolism Studies: Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Drug Impurity Profiling: Used in method development and validation to identify and quantify potential deuterated impurities or metabolites.
• Clinical Research Assays: Critical component in regulated bioanalysis for therapeutic drug monitoring (TDM) and clinical trial sample analysis.
• Pharmaceutical Quality Control: Supports analytical method development and validation in drug substance and drug product manufacturing.
• Isotope Dilution Mass Spectrometry (IDMS): Serves as the ideal spike-in standard for achieving high-precision, definitive measurements.

Basic Information

Product Name	Intedanib-D8
CAS No.	1624587-87-6
Molecular Formula	C31H19D8N5O4
Molecular Weight	541.60 g/mol (approx.)
Synonyms	Nintedanib-d8; BIBF 1120-d8; (Z)-N-[4-[(1-Methylindol-2-yl)carbonyl]thiomorpholin-3-yl]-N'-[4-methyl-5-[2-(1,1,2,2,3,3,4,4-octadeuteriopyrrol-1-yl)pyrimidin-4-yl]thiazol-2-yl]urea; 1H-Indole-2-carboxylic acid, 1-methyl-, 3-[[[[4-methyl-5-[2-(2,3,4,5-tetradeuterio-1H-pyrrol-1-yl)-4-pyrimidinyl]-2-thiazolyl]amino]carbonyl]amino]-4-(tetradeuteriomorpholinyl) butyl ester; Vargatef-d8; Ofev-d8
EINECS	Contact for details

Quality Control

Every batch of Intedanib-D8 is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data to ensure identity, purity, and isotopic enrichment meet the exacting standards required for research and bioanalysis. A detailed Certificate of Analysis (COA) is supplied with each product, reporting results for assay, isotopic purity, chemical purity (by HPLC), and identification (by NMR and MS).

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below under an inert atmosphere. This product is hygroscopic (moisture-sensitive). Allow the sealed vial to equilibrate to room temperature before opening to minimize moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (NMR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity	≥98 atom % D
Chemical Purity	≥95.0%
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.