Description

o-Demethyl Vandetanib-D4 is a deuterated isotopologue of a key pharmaceutical intermediate, specifically designed for advanced research and development applications. This high-purity compound is critical for conducting precise metabolic and pharmacokinetic studies, enabling the development of more effective and targeted therapeutic agents. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and academic institutions focused on oncology drug discovery and analytical method development.

Application

• Pharmaceutical Reference Standard: Serves as a certified internal standard for the accurate quantification of Vandetanib and its metabolites in biological matrices using LC-MS/MS.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Essential for tracing metabolic pathways, conducting mass balance studies, and investigating the absorption, distribution, metabolism, and excretion (ADME) profile of Vandetanib.
• Analytical Method Development: Used to develop and validate highly sensitive and specific bioanalytical assays in compliance with GLP and FDA/EMA guidelines.
• Isotope Dilution Mass Spectrometry: Employed as a stable isotope-labeled analog to enhance the precision and accuracy of quantitative mass spectrometric analyses.
• Impurity Profiling and Characterization: Aids in the identification and structural elucidation of process-related impurities and degradants in active pharmaceutical ingredient (API) batches.

Basic Information

Product Name	o-Demethyl Vandetanib-D4
CAS No.	1346599-97-0
Molecular Formula	C22H20D4ClFN4O2
Molecular Weight	425.92 g/mol (approximate)
Synonyms	N-(4-Bromo-2-fluorophenyl)-6-methoxy-7-[(1-methylpiperidin-4-yl)methoxy]quinazolin-4-amine-d4; Vandetanib D4 Impurity; Vandetanib-d4 Metabolite; ZD6474-d4 derivative; 4-[(4-Bromo-2-fluorophenyl)amino]-6-methoxy-7-[(1-methyl-4-piperidinyl)methoxy]quinazoline-d4; Deuterated Vandetanib Impurity; Stable Isotope Labeled Vandetanib Intermediate
EINECS	Contact for details

Quality Control

Every batch of o-Demethyl Vandetanib-D4 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and isotopic enrichment. Our quality commitment includes comprehensive characterization by NMR, HPLC, and mass spectrometry. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming specifications for chemical purity, isotopic purity (D-enrichment), and related substances.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

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 (D-enrichment)	≥ 98 atom % D
Water Content (KF)	≤ 0.5%
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.