Description

Afatinib Impurity Sf is a high-purity reference standard used for the analytical profiling and quality control of the active pharmaceutical ingredient Afatinib. This impurity is critical for pharmaceutical manufacturers and analytical laboratories to ensure the safety, efficacy, and regulatory compliance of their drug products. It is primarily utilized in research and development, method validation, and stability studies within the pharmaceutical and biotechnology sectors.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Afatinib API batches.
• Essential for analytical method development and validation (HPLC, LC-MS) in quality control laboratories.
• Supports pharmaceutical research into the degradation pathways and stability profile of Afatinib.
• Critical component for preparing impurity specifications in regulatory filings (e.g., FDA, EMA).
• Used in stability-indicating studies to monitor impurity levels over the drug's shelf life.
• Facilitates comparative testing and quality assurance for generic drug manufacturers.

Basic Information

Product Name	Afatinib Impurity Sf
CAS No.	2223677-62-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Afatinib Related Compound Sf; Afatinib Impurity; 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
EINECS	Contact for details

Quality Control

Our Afatinib Impurity Sf is manufactured under strict quality systems to ensure the highest standards of purity and consistency. Each batch is rigorously tested using validated analytical methods, including HPLC and mass spectrometry, to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with every shipment, detailing all test results and confirming compliance with in-house specifications suitable for pharmaceutical analysis.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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