Description

n-Desmethyl Dovitinib-D8 is a deuterated internal standard critical for the precise quantification of the active pharmaceutical ingredient Dovitinib and its metabolites in complex biological matrices. This high-purity reference material is essential for ensuring the accuracy and reliability of pharmacokinetic and bioanalytical studies. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in drug development and clinical research.

Application

• Bioanalytical Method Development and Validation: Serves as a stable isotope-labeled internal standard for Liquid Chromatography-Mass Spectrometry (LC-MS/MS) assays to quantify Dovitinib and its desmethyl metabolite in plasma, serum, and tissue samples.
• Pharmacokinetic (PK) and Toxicokinetic (TK) Studies: Enables accurate measurement of drug concentration-time profiles, supporting critical ADME (Absorption, Distribution, Metabolism, Excretion) evaluations during preclinical and clinical trials.
• Metabolite Profiling and Identification: Aids in the structural elucidation and quantification of Dovitinib metabolites, facilitating a deeper understanding of its metabolic pathways.
• Quality Control in Drug Manufacturing: Used in analytical laboratories for method transfer and as a system suitability standard to ensure the consistency and precision of impurity profiling methods for active pharmaceutical ingredients (APIs).
• Regulatory Submission Support: Provides the traceable and characterized reference material required for generating compliant data packages for submissions to agencies like the FDA and EMA.

Basic Information

Product Name	n-Desmethyl Dovitinib-D8
CAS No.	1246814-93-6
Molecular Formula	C₂₁H₁₃D₈FN₆O
Molecular Weight	407.48 g/mol
Synonyms	Dovitinib Desmethyl-D8; Dovitinib N-Desmethyl-D8; TKI258 N-Desmethyl-D8; (3Z,5Z)-3-[(2,4-Dimethyl-1H-pyrrol-5-yl)methylene]-5-[(1H-pyrrol-2-yl)methylene]-1H-pyrrol-2-one-D8; Deuterated n-Desmethyl Dovitinib; Dovitinib Metabolite Standard-D8; Internal Standard for Dovitinib; 4-Amino-5-fluoro-3-[6-(4-methylpiperazin-1-yl)-1H-benzimidazol-2-yl]quinolin-2(1H)-one N-Desmethyl-D8
EINECS	Contact for details

Quality Control

Every batch of n-Desmethyl Dovitinib-D8 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and isotopic enrichment meet the stringent requirements for bioanalytical reference standards. Our quality commitment includes comprehensive characterization by NMR, MS, and HPLC. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific data including assay, chemical purity, isotopic purity (D-enrichment), and residual solvent content.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry, controlled environment. This compound is hygroscopic (moisture-sensitive). For long-term storage, consider storage under an inert atmosphere. 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 (HPLC-MS)	Conforms
Identification (NMR)	Conforms
Purity (HPLC)	≥98.0%
Isotopic Purity (D-enrichment)	≥98 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.