Description

Afatinib Impurity n-Oxide is a specified degradation product and process-related impurity of the active pharmaceutical ingredient Afatinib, a tyrosine kinase inhibitor used in targeted cancer therapy. This compound is critical for pharmaceutical research and development, serving as a certified reference standard for analytical method development, validation, and quality control. It is essential for laboratories in the pharmaceutical and biotechnology sectors, particularly those focused on oncology drug development, regulatory compliance, and ensuring the safety and efficacy of Afatinib-based medications.

Application

• Primary use as a certified reference standard for the identification and quantification of Afatinib impurities in drug substances and products.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) for regulatory filings (e.g., ICH guidelines).
• Used in stability studies and forced degradation studies to understand the degradation pathways of Afatinib.
• Essential for quality control (QC) and quality assurance (QA) laboratories to monitor impurity profiles during manufacturing.
• Supports pharmacopoeial standards development and compliance testing for Afatinib APIs and finished dosage forms.
• Valuable for academic and contract research organizations (CROs) conducting research on kinase inhibitors and their metabolites.

Basic Information

Product Name	Afatinib Impurity n-Oxide
CAS No.	2413212-11-8
Molecular Formula	C24H25ClFN5O4
Molecular Weight	501.94 g/mol
Synonyms	Afatinib N-Oxide; Afatinib Related Compound n-Oxide; (2E)-N-[4-(3-Chloro-4-fluorophenyl)amino]-7-[[(3S)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4-(dimethylamino)-2-butenamide N-Oxide; BIBW 2992 N-Oxide; Gilotrif Impurity n-Oxide; Giotrif Impurity n-Oxide; Tovok Impurity n-Oxide
EINECS	Contact for details

Quality Control

Every batch of Afatinib Impurity n-Oxide is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to meet the stringent requirements of pharmaceutical reference standard applications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters. We support compliance with ICH Q3A, Q3B, and Q6A guidelines.

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 in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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