Description

Afatinib Impurity 41 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Afatinib. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by accurately identifying and quantifying related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of Afatinib-based oncology treatments.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of Afatinib API and finished dosage forms.
• Analytical Method Development: Used to establish and optimize chromatographic conditions (HPLC, UPLC) for the precise separation and detection of impurities in Afatinib.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Stability Studies: Employed as a marker to monitor the formation of degradation products during forced degradation and long-term stability studies of Afatinib.
• Process Chemistry Research: Used by R&D scientists to understand and control impurity formation during the synthesis and purification steps of Afatinib manufacturing.
• Pharmacopoeial Testing: Supports testing in compliance with pharmacopoeial monographs (e.g., USP, EP) that specify limits for known and unknown impurities.

Basic Information

Product Name	Afatinib Impurity 41
CAS No.	69169-63-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Afatinib Related Compound 41; Afatinib Impurity F; Afatinib EP Impurity F; Afatinib USP Impurity; (2E)-N-[4-[(3-Chloro-4-fluorophenyl)amino]-7-[[(3S)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4-(dimethylamino)-2-butenamide Impurity; Giotrif Impurity 41; Gilotrif Impurity 41
EINECS	Contact for details

Quality Control

Every batch of Afatinib Impurity 41 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques such as HPLC, LC-MS, and NMR to ensure compliance with pharmacopoeial and client-specific standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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 material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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