Description

Afatinib Impurity CAS NO 2406199-31-1 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the oncology drug Afatinib. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method validation, stability studies, and the synthesis of Afatinib.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the analytical method development and validation of Afatinib drug substance and product.
• Quality Control & Assurance (QC/QA): Used for routine batch testing to monitor and control impurity profiles, ensuring drug purity meets pharmacopeial standards (e.g., USP, EP, ICH).
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed characterization and control of impurities.
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions during drug shelf-life studies.
• Process Chemistry R&D: Used by synthetic chemists to understand and optimize the Afatinib manufacturing process to minimize the formation of this specific impurity.
• Academic & Clinical Research: Supports investigative studies on the metabolism, pharmacokinetics, and toxicity profile of Afatinib and its related compounds.

Basic Information

Product Name	Afatinib Impurity
CAS No.	2406199-31-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Afatinib Related Compound; Afatinib Process Impurity; Afatinib Degradant; (2E)-N-[4-[(3-Chloro-4-fluorophenyl)amino]-7-[[(3S)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4-(dimethylamino)-2-butenamide Impurity; Giotrif Impurity; Gilotrif Impurity; BIBW 2992 Impurity
EINECS	Contact for details

Quality Control

Every batch of Afatinib Impurity 2406199-31-1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profile.

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 compound is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to prevent degradation upon exposure to atmospheric humidity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.