Description

Nintedanib 13Cd3 is a stable isotope-labeled analog of the tyrosine kinase inhibitor Nintedanib, specifically deuterated at three positions with carbon-13. This high-purity reference standard is essential for ensuring the accuracy and reliability of quantitative bioanalytical methods, particularly in pharmacokinetic and metabolism studies. It is a critical tool for pharmaceutical researchers, contract research organizations (CROs), and analytical laboratories developing and validating LC-MS/MS assays for Nintedanib.

Application

• Internal Standard for LC-MS/MS Analysis: Primary use as a stable isotope-labeled internal standard for the precise quantification of Nintedanib in biological matrices (plasma, serum, tissue).
• Pharmacokinetic (PK) and Toxicokinetic (TK) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Drug Metabolism Studies: Used in metabolite identification and profiling to understand the biotransformation pathways of Nintedanib.
• Bioanalytical Method Development & Validation: Serves as a critical component for developing robust, selective, and sensitive analytical methods compliant with FDA and ICH guidelines.
• Quality Control in Pharmaceutical Manufacturing: Can be utilized in impurity profiling and assay validation of drug substance and product.

Basic Information

Product Name	Nintedanib 13Cd3
CAS No.	1624587-84-3
Molecular Formula	C31H30N5O4 • 13C3D3
Molecular Weight	~ 648.7 g/mol (exact mass varies with isotope enrichment)
Synonyms	Nintedanib-d3 (13C3)
Nintedanib (phenyl-13C6, d5)
BIBF 1120-13Cd3
Intedanib-13Cd3
Methyl (3Z)-3-[[4-[N-Methyl-2-(4-methylpiperazin-1-yl)acetamido]phenylamino](phenyl-13C6,d5)methylidene]-2-oxo-1H-indole-6-carboxylate
Vargatef-13Cd3
Ofev-13Cd3
EINECS	Contact for details

Quality Control

Our Nintedanib 13Cd3 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for chemical purity, NMR and MS for structural confirmation and isotopic enrichment verification. We provide a comprehensive Certificate of Analysis (COA) detailing purity, isotopic purity, and analytical data, supporting compliance with ICH Q2(R1) guidelines for method validation.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below for long-term stability. Allow the vial to equilibrate to room temperature in a desiccator before opening to minimize moisture uptake. For optimal performance, store the product under inert atmosphere after initial opening.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity	≥ 99 atom % 13C; ≥ 98 atom % D
Chemical Purity	≥ 95% (by NMR)
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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