Description

4-Hydroxy 4-Dedimethylamino Afatinib is a key pharmaceutical intermediate and metabolite in the synthesis and study of advanced tyrosine kinase inhibitors. This compound is of significant interest for research and development within the oncology drug discovery sector, particularly for modifying the pharmacokinetic and pharmacodynamic profiles of therapeutic agents. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and academic research institutions focused on developing next-generation cancer treatments.

Application

• Pharmaceutical Intermediate: Critical building block in the synthesis of novel Afatinib analogs and derivatives for enhanced therapeutic efficacy.
• Metabolite Reference Standard: Used as a certified reference material (CRM) in bioanalytical studies for drug metabolism and pharmacokinetics (DMPK) research.
• Active Pharmaceutical Ingredient (API) Development: Serves as a precursor in the research and scale-up of new oncology APIs targeting EGFR and other kinases.
• Biochemical Research: Employed in in vitro studies to investigate structure-activity relationships (SAR) and inhibition mechanisms of kinase pathways.
• Quality Control & Impurity Profiling: Acts as a known impurity or degradation product standard for analytical method development and validation in API manufacturing.

Basic Information

Product Name	4-Hydroxy 4-Dedimethylamino Afatinib
CAS No.	2121530-37-6
Molecular Formula	C24H25ClFN5O3
Molecular Weight	485.94 g/mol
Synonyms	4-Hydroxyafatinib Impurity; Afatinib N-Oxide Derivative; (2E)-N-[4-(3-Chloro-4-fluorophenyl)amino]-7-[[(3S)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4-(dimethylamino)-2-butenamide N-Oxide; 4-Demethyl-4-hydroxy Afatinib; Afatinib Metabolite M; BIBW 2992 Metabolite; N-[4-(3-Chloro-4-fluoroanilino)-7-[(S)-(tetrahydrofuran-3-yl)oxy]quinazolin-6-yl]-4-(dimethylamino)but-2-enamide 4-Oxide
EINECS	Contact for details

Quality Control

Our 4-Hydroxy 4-Dedimethylamino Afatinib is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC, NMR, and MS, to ensure high purity and identity confirmation, meeting the stringent requirements for pharmaceutical research and development. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your regulatory and quality assurance needs.

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 must be kept under inert atmosphere or in a desiccator after opening to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Single Unknown Impurity (HPLC)	≤ 0.5%
Total Impurities (HPLC)	≤ 2.0%

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