Description

Hydroxy Vandetanib CAS NO 910298-61-2 is a key pharmaceutical intermediate and reference standard, specifically a hydroxylated derivative of the tyrosine kinase inhibitor Vandetanib. This compound is of significant value in the research and development of targeted cancer therapies, particularly for medullary thyroid cancer and other solid tumors. It is primarily utilized by pharmaceutical R&D laboratories, academic research institutions, and quality control departments for analytical method development, metabolite studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used for the identification, assay, and impurity qualification of Vandetanib active pharmaceutical ingredient (API) and finished drug products.
• Metabolite Research: Serves as a critical standard in pharmacokinetic and metabolic pathway studies to understand the biotransformation of Vandetanib in biological systems.
• Process Impurity Control: Employed in the development and validation of manufacturing processes for Vandetanib to monitor and control specific process-related impurities.
• Analytical Method Development: Essential for calibrating High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS) methods in quality control laboratories.
• Preclinical and Clinical Research: Used in bioanalytical studies to support drug safety and efficacy evaluations during non-clinical and clinical trial phases.
• Regulatory Compliance and Documentation: Provides certified material for generating data to meet regulatory submission requirements (e.g., for FDA, EMA) for drug approval.

Basic Information

Product Name	Hydroxy Vandetanib
CAS No.	910298-61-2
Molecular Formula	C22H24BrFN4O3
Molecular Weight	491.36 g/mol
Synonyms	N-(4-Bromo-2-fluorophenyl)-6-hydroxy-4-[(4-methyl-1-piperazinyl)methyl]-2-quinazolinamine; Vandetanib Hydroxy Impurity; Vandetanib Metabolite; Vandetanib Related Compound; ZD6474 Hydroxy Impurity; UNII-8VZU8B8WQI; 4-[(4-Methylpiperazin-1-yl)methyl]-N-(4-bromo-2-fluorophenyl)-6-hydroxyquinazolin-2-amine
EINECS	Contact for details

Quality Control

Our Hydroxy Vandetanib is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identity confirmation by IR and MS, and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical research and development. A detailed Certificate of Analysis (COA) with batch-specific data is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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